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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

Understanding the Role of Nonchemical Stressors and Developing Analytic Methods for Cumulative Risk Assessments

This is the initial announcement of this funding opportunity.

Funding Opportunity Number:

    EPA-G2009-STAR-E1: Developing Statistical and Other Analytical Techniques for Cumulative Risk Assessments
    EPA-G2009-STAR-E2: Evaluating the Interaction of Nonchemical and Chemical Stressors

Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: February 13, 2009
Solicitation Closing Date: June 17, 2009, 4:00 pm Eastern Time

Eligibility Contact: William Stelz (stelz.william@epa.gov); phone: 703-347-8039
Electronic Submissions: Ron Josephson (josephson.ron@epa.gov); phone: 703-308-0442
Technical Contact: 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 from interdisciplinary teams to address research needs that currently limit the ability to conduct cumulative risk assessments. Exposure to different combinations of environmental stressors can contribute to increased risk for negative health consequences. It has become clear that cumulative risk assessments should include both chemical and nonchemical stressors, exposures from multiple routes, and factors that differentially affect exposure or toxicity to communities. This RFA is focusing on two challenges that exist in conducting cumulative risk assessments: (a) STAR-E1: The development of statistical and other analytical techniques that will enable the analysis of disparate types of data, and (b) STAR-E2: The evaluation of the combined effects of nonchemical and chemical stressors.

Award Information:
Anticipated Type of Award: Grant or cooperative agreement
Estimated Number of Awards: Approximately 9 awards
Anticipated Funding Amount: Approximately $8 million total for all awards
Potential Funding per Award: Up to a total of $750,000 for STAR-E1 and up to a total of $1,250,000 for STAR-E2, including direct and indirect costs, with a maximum duration of 4 years. Cost-sharing is not required. Proposals with budgets exceeding the total award limits 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:
To apply under this solicitation, use the application package available at Grants.gov (for further submission information see Section IV.E. “Submission Instructions and other Submission Requirements”).  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/. If your organization is not currently registered with Grants.gov, you need to allow approximately one week to complete the registration process.  This registration, and electronic submission of your application, must be performed by an authorized representative of your organization.

If you do not have the technical capability to utilize the Grants.gov application submission process for this solicitation, call 1-800-490-9194 or send a webmail message to http://www.epa.gov/ncer/contact_us.html at least 15 calendar working days before the submission deadline to assure timely receipt of alternate submission instructions.  In your message  provide the funding opportunity number and title of the program, specify that you are requesting alternate submission instructions, and provide a telephone number, fax number, and an email address, if available.  Alternate instructions will be e-mailed whenever possible.  Any applications submitted through alternate submission methods must comply with all the provisions of this RFA, including Section IV, and be received by the solicitation closing date identified above.

Agency Contacts:
Eligibility Contact: William Stelz (stelz.william@epa.gov); phone: 703-347-8039
Electronic Submissions: Ron Josephson (josephson.ron@epa.gov); phone: 703-308-0442
Technical Contact: Deborah Segal (segal.deborah@epa.gov); phone: 703-347-8528

I. FUNDING OPPORTUNITY DESCRIPTION

A. Introduction
The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) grants program, is seeking applications from interdisciplinary teams to address research needs that currently limit the ability to conduct cumulative risk assessments. Exposure to different combinations of environmental stressors can contribute to increased risk for negative health consequences. It has become clear that cumulative risk assessments should include both chemical and nonchemical stressors, exposures from multiple routes, and factors that differentially affect exposure or toxicity to communities. For this Request for Applications (RFA), environmental stressor is defined as a chemical, physical, biological, or social entity that can cause an adverse response to humans, and community refers to a group of people that share a common characteristic or characteristics, for example, ethnicity, socioeconomic status, or geographic location. Some of these factors may contribute to negative health effects, but others might increase resiliency, which is the ability to overcome stressful conditions. How these factors interact has tremendous public health implications. For example, a pollutant exposure that is benign to children living in a wealthy community may harm children living in a less advantaged environment. In order to protect the most sensitive individuals, an understanding of the complex interactions of various stressors is critical.

Because risk assessments have traditionally focused on the effects of one chemical on one individual via a single route or pathway and have not considered the role of nonchemical stressors and other community-related factors, conducting cumulative risk assessments poses many challenges. This RFA is focusing on two of the challenges: (a) STAR-E1: The development of statistical and other analytical techniques that will enable the analysis of disparate types of data, and (b) STAR-E2: The evaluation of the combined effects of nonchemical and chemical stressors. In order to address these challenges successfully, collaborations will need to be developed among biomedical scientists, public health scientists, mathematical and statistical scientists, social scientists, and community members.

B. Background
Several reports have stressed the need to evaluate risks from multiple stressors, as opposed to a single one. Two such reports are “Science and Judgment in Risk Assessment” (National Research Council, 1994) and “Risk Assessment and Risk Management in Regulatory Decision-Making (Presidential/Congressional Commission on Risk Management, 1997). In addition, the Food Quality Protection Act of 1996 specifically mandates the consideration of cumulative risk to pesticides with a common mechanism of action in the human health risk assessment of pesticides.

One research objective in EPA’s Human Health Research Strategy (www.epa.gov/NHEERL/humanhealth/HHRS_final_web.pdf(67 pp, 1.5 MB)) is to develop “approaches to assess population-based cumulative risk, including those involving exposure to stressors other than pollutants.”  Additionally, EPA’s Framework for Cumulative Risk Assessment defines “cumulative risk” broadly to include nonchemical stressors, such as “current physical and mental health status and past exposure histories…and social factors such as community property values, sources of income, level of income, and standard of living” (EPA’s Framework for Cumulative Risk Assessment, p. 51). The Framework calls for (a) an understanding of the combined effects of more than one stressor, (b) a consideration of nonchemical stressors, (c) a focus on vulnerable populations, and (d) the use of community expertise for place-based or population-based risk assessments.

To help determine the most pressing research needs for cumulative risk assessment and in response to interests of EPA’s Regional risk assessors, Program Offices, Office of Environmental Justice, and Office of Children’s Health Protection and Environmental Education, EPA’s National Center for Environmental Research (NCER) and National Center for Computational Toxicology sponsored a “Workshop on Research Needs for Community-Based Risk Assessment” in October 2007. Workshop participants, who represented EPA, other federal agencies, academia, and private organizations, generated an extensive list of research needs that included data generation, tool and model development, infrastructure improvements, basic research on nonchemical stressors, and training in community-based participatory research (CBPR). As a first step, this RFA will focus on two needs that were repeatedly identified: The development of techniques that will enable the analysis of disparate types of data and the evaluation of the combined effects of nonchemical and chemical stressors. This RFA will also require a CBPR component as discussed in more detail in Section D: Specific Research Areas of Interest/Expected Outputs and Outcomes.

Although representing only one explanation for how nonchemical stressors might modify toxicity resulting from environmental exposures, the framework presented below (Morello-Frosch & Shenassa, 2006) is one example depicting the complexities that exist when considering individual as well as community-level factors.  The authors theorize that an individual’s allostatic load is the cumulative physiologic degradation that results from a lifetime of chronic stress. This influences internal dose, response and resilience, health effect, and the ability to recover. This RFA is seeking research to help elucidate how different (including other chemical and nonchemical) stressors alter the internal dose, resilience, health effects, or ability to recover from exposures to environmental contaminants.

STAR-E1: Developing Statistical and Other Analytical Techniques for Cumulative Risk Assessments

Several EPA programs have released guidance documents to encourage analytic methods development for cumulative risk assessments. The documents call for consideration of multiple stressors and their interactions with one another.  This could require the analysis of multiple pathways, durations, sources and routes of exposure; analysis of the multiple effects and impacts; inclusion of nonchemical stressors; and a quantification of risks (U.S. EPA, 2003, 2007). In order to foster this more integrated view of environmental risk, the documents acknowledge that traditional analytical techniques—such as estimating reference doses for single chemicals--will increase in complexity.  Refinement of existing methodological approaches or the development of novel ones is required to facilitate a better understanding of the cumulative impacts of multiple chemical and nonchemical stressors on a population. Especially needed are quantitative functions relating health effects to levels of multiple stressors.

Analyzing aggregate measures. The reality that populations are exposed to multiple chemicals through multiple paths of exposure over time has spurred much research on the toxicology of chemical mixtures. EPA staff (2007) reviewed the literature on some of the more recent and innovative approaches in this field.  These approaches include the use of biomarkers (e.g., metabolites in urine and blood samples) and DNA microarrays to collect data on, respectively, the mix of chemical concentrations to which different populations are exposed and the consequent change in gene expression. Techniques that could aid the analysis of these types of measurements, chemical mixtures, and clusters of gene expression patterns include parametric and nonparametric techniques, such as principal component analysis and canonical correlation, and potentially other methods. Ultimately, such work might lead to the development of models that explain mechanisms of toxicity interactions and classification schemes for toxic mixtures. Advanced statistical and analytical methods are needed to determine the overall body burden from the totality of chemicals to which humans are exposed.

Evaluating chemical and nonchemical stressors that contribute to vulnerability. Compounding the complexity of chemical mixtures, the vulnerability of an organism to negative health outcomes is strongly associated with both social environment (Krieger, 2007) and exposure to chemicals (Weiss and Bellinger, 2007), as well as to genetic susceptibility. Weiss and Bellinger argue that social factors—such as parental IQ, family income, marital status, prenatal care, maternal drug use, and family caregiving—are not so much confounders, but rather modifiers of the etiology being investigated. The traditional statistical approach in epidemiological studies for examining whether multiple risk factors modify observed associations between an exposure of interest and health status has been through stratified analyses or the use of interaction terms in regression models. However, the simultaneous consideration of multiple chemical and nonchemical stressors raises several statistical and methodological issues that have not been resolved. Better analytical methods are needed to determine how multiple variables influence an individual’s vulnerability.

Combining information from disparate studies to evaluate risk. Further development is also needed to integrate multiple levels of analysis. In order to better understand the cumulative impact of chemical and nonchemical stressors, it is likely that data and models of exposure and effects will need to be integrated across multiple studies and across multiple scales of time and space. Calder et al. (2008) related ambient particulate matter concentrations to mortality using a Bayesian hierarchical model that incorporated a spatial model and an exposure simulator and modeled the strength of temporally lagged effects. Harris and colleagues (2002) developed regression diagnostic techniques to correlate exposure questionnaires with urine collection data, absorbed dose estimations (from both dermal and inhalation exposures), and equipment variations with multiple pesticides use. Methods involving multilevel analyses are needed to coherently analyze data and to evaluate impacts at both the individual- and community-levels.

STAR E2: Evaluating the Interaction of Nonchemical and Chemical Stressors

As discussed in the National Environmental Justice Advisory Council (NEJAC) 2004 report, “Ensuring Risk Reduction in Communities with Multiple Stressors: Environmental Justice and Cumulative Risks/Impacts,” and mentioned above, a need exists to better characterize risks posed by exposures to multiple chemicals and to incorporate social and nonchemical factors into cumulative risk assessments. Nonchemical stressors are critical to consider in risk assessments because many chemical exposures occur in the context of multiple social disadvantages, which frequently impair human health and well being (Rauh et al., 2004). 

Determining which nonchemical stressors exacerbate chemical exposures. Elevated psychosocial stress has been shown to contribute to several adverse health outcomes, most notably, to cardiovascular disease. The physiological mechanism by which psychosocial stress leads to health effects is due, at least in part, to elevated circulating glucocorticoids, or stress hormones, which are regulated by the hypothalamic-pituitary-adrenal (HPA) axis. Research on the physiologic impacts of nonchemical stressors has focused primarily on the stress experienced by those living in disadvantaged communities. The extent of this stress is often represented by some measure of socioeconomic status (SES), which takes into account income, education, and occupation. SES has consistently been associated with health outcomes, such that people of lower SES generally have poorer health outcomes than those of higher SES (Adler et al., 1994). However, understanding which components of SES have the greatest impact on environmental exposure-related health outcomes is critical. For example, the stress resulting from overcrowding, poverty, and violence in one’s neighborhood or the lack of healthcare, poor nutritional status, or unhealthy behaviors, individually or in combination, may increase vulnerability to toxic effects. Interestingly, researchers have found that the neighborhood in which one resides influences one’s health more than an individual’s SES (Kawachi & Berkman, 2003). 

One example of a chemical-nonchemical interaction is that of lead and psychosocial stress, which both act (through the HPA axis) on the dopamine/glutamate mesocorticolimbic systems of the brain (Virgolini et al., 2006). A body of research on lead toxicity has demonstrated adverse health effects following environmental exposures only when stress is also a factor.  For example, Tong et al. (2000) found that children from socially disadvantaged backgrounds were more sensitive to lead than those of a higher socioeconomic status. Schneider et al. (2001) discovered that lead-exposed rats in an impoverished environment had spatial learning deficits and significantly decreased neurotrophic factor gene expression in the hippocampus, whereas rats reared in an enriched environment were protected against the behavioral and neurochemical toxicity of lead (Guilarte et al., 2003). 

Nonchemical stress exacerbates the toxicity of other chemicals as well. Claugherty and colleagues (2007) found an association between traffic-related air pollution and asthma solely among children exposed to violence, suggesting a synergistic relationship between exposure to air pollution and violence. Others have found an interactive effect of prenatal environmental tobacco smoke and material hardship (Rauh et al., 2004). In addition to psychosocial nonchemical stressors, nutritional status has been demonstrated to affect the toxic response to chemical exposures. For example, iron and calcium deficiencies increase the toxicity resulting from heavy metal exposures.

Understanding the biological role of nonchemical stressors in mediating chemical toxicity. Little is known regarding how nonchemical stressors potentiate the negative health effects resulting from exposure to the vast majority of toxic chemicals. Understanding interactions between chemical and nonchemical stressors will require knowledge of toxicant-specific biological mechanisms of action, as well as stress response mechanisms of action. Additional research is needed to better understand the physiological health impacts, including the neurobiology and immunological effects of nonchemical stressors and how nonchemical stressors can affect health outcomes associated with chemical exposures.

Community-Based Participatory Research (CBPR)

The potential for CBPR to enhance environmental protection has been recognized by EPA. This concept promotes a holistic approach to protecting the environment that involves diverse stakeholders who develop a plan aimed at meeting environmental, economic and social goals in a sustainable manner for a defined geographic area. Community participation enables the identification of variables that might otherwise have been missed. Community and stakeholder involvement is critical to obtaining community knowledge and to understanding complex cumulative exposures (EPA, 2003; NEJAC, 2004). Community members understand community practices that may influence exposures. In addition, because population-based cumulative risk assessments involve community-level stressors and measures of vulnerability, which can help to inform decision making at the local level, earning the trust of community members is necessary.  To understand the key concepts of CBPR, see Israel et al. (2001).

The specific Strategic Goal and Objective from the 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 http://www.epa.gov/ocfo/plan/2006/entire_report.pdf (PDF) (184 pp, 11.56 MB, about PDF)

C. Authority and Regulations
The authority for this RFA and resulting awards is contained in the Clean Air Act, Section 103, 42 U.S.C. 7403; the Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, 7 U.S.C. 136r; the Safe Drinking Water Act, Section 1442, 42 U.S.C. 300j-1; the Clean Water Act, Section 104, 33 U.S.C. 1254; and the Toxic Substances Control Act, Section 10, 15 U.S.C. 2609.

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

Applicable regulations include: 40 CFR Part 30 (Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations), 40 CFR Part 31 (Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments) and 40 CFR Part 40 (Research and Demonstration Grants). Applicable OMB Circulars include: OMB Circular A-21 (Cost Principles for Educational Institutions) relocated to 2 CFR Part 220, OMB Circular A-87 (Cost Principles for State, Local and Indian Tribal Governments) relocated to 2 CFR Part 225, OMB Circular A-102 (Grants and Cooperative Agreements With State and Local Governments), OMB Circular A-110 (Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals and Other Non-Profit Organizations) relocated to 2 CFR Part 215, and OMB Circular A-122, (Cost Principles for Non-Profit Organizations) relocated to 2 CFR Part 230.

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 Agency is soliciting research that will result in an improved ability to conduct cumulative risk assessments. Anticipated outputs of this research include statistical and computational tools, models and approaches for analyzing disparate types of data required for risk assessments.  It also includes the generation of data evaluating the effects of multiple chemical and nonchemical stressors.  The desired outcome of this research is a better understanding of the combined effects of nonchemical and chemical stressors and the development of statistical and computational tools, models, and approaches for analyzing the disparate types of data required by cumulative risk assessments.  The research will also require involvement by community members in the research process.

There are two distinct areas of research covered by this solicitation. Responsive applications must propose to do one of the following:

  • STAR-E1: Develop analytic techniques to characterize effects and health risks at the community and individual levels; synthesize information from multiple datasets; extrapolate data among datasets and/or across communities; develop quantitative functions relating a health outcome to levels of multiple stressors; and characterize the uncertainty and/or limitations associated with these studies.
  • STAR-E2: Evaluate the combined effects of nonchemical and chemical stressors.

STAR-E1: Developing Statistical and Other Techniques for Cumulative Risk Assessments.This research should be primarily concerned with the following related questions: (1) How can research be conducted and data from multiple sources be synthesized across space and time to help elucidate the interaction of organisms with multiple stressors in their physical and social environments? (2) How can biological mechanisms be integrated to gain a systems-wide, multi-scale understanding of interactions at the organism and population levels in terms of an individual’s experience of stress and in relation to intrinsic and extrinsic factors contributing to vulnerability or resilience? (3) How can quantitative and qualitative data be integrated to provide some metric of risk?

For STAR-E1, the focus must be on exposures to one of the following: (1) multiple chemicals, (2) a chemical and a nonchemical stressor together, (3) multiple chemicals and a non-chemical stressor, (4) a chemical and multiple nonchemical stressors, or (5) multiple chemicals and multiple nonchemical stressors. In addition, for all developed tools, models or approaches, uncertainties and/or limitations must be characterized. The use of existing datasets is acceptable, but not required.

Research responsive to STAR-E1 must develop tools, models or approaches to accomplish at least one of the following:

  • Integrate research results and information from multiple studies, multiple data sources, and across multiple scales of time and/or space to address various components within cumulative risk assessment.
  • Determine dose/concentration-response curves when multiple stressors exist.
  • Develop metrics or methodologies for assessing and integrating the cumulative effects of multiple sources of stress, including quantitative and qualitative indicators of nonchemical sources of stress.

STAR-E2: Evaluating the Interaction of Nonchemical and Chemical Stressors. This research should be primarily concerned with the following related questions: (1) What is the role of nonchemical stressors in the exacerbation of the health effects resulting from chemical exposures? (2) What is the mechanism of action for nonchemical and chemical stressors? Are they the same, similar, or different? Do they interact and/or intersect? (3) Can dose-response curves and physiologically based pharmacokinetic (PBPK) and physiologically based pharmacodynamic (PBPD) models be developed to incorporate nonchemical stressors? (4) Do different nonchemical stressors modify toxicity responses in a similar way and to the same degree?

For STAR-E2, animal studies are acceptable as are epidemiological investigations focused on humans. Research responsive to STAR-E2 must accomplish at least one of the following:

  • Determine the biological impact of psychosocial stress and its interaction with chemical exposures, including mechanisms of action and the resulting health consequences. This may consider exposure influences, such as sequence and timing. It might also consider lifestage.
  • Develop dose-response models for combined exposures to chemical and nonchemical stressors. Effects of timing of the exposures may be considered if appropriate.
  • Incorporate psychosocial stress into chemical or class-specific PBPK and PBPD models.
  • Identify which nonchemical stressors exacerbate negative health outcomes resulting from chemical exposures for particular populations or life stages.

Community-Based Participatory Research (CBPR)

CBPR is defined as a collaborative process of research involving researchers and community representatives. The process of scientific inquiry is such that community members, persons affected by the health condition, disability or issue under study, or other key stakeholders in the community's health, have the opportunity to participate in each phase of the work. Community-based organizations refer to organizations that may be involved in the research process as members or representatives of the community. Although not an exhaustive list, organizations as varied as Tribal governments and colleges, state or local governments, independent living centers, health delivery organizations (e.g., hospitals), health professional associations, non-governmental organizations, and federally qualified health centers are possible community partners.
A CBPR plan will be required for each proposed project. Although a range of levels of community involvement can be considered CBPR, CBPR is characterized by substantial community input in the project. In the application, the applicant will need to justify the level of community involvement that he or she has proposed. For additional information on CBPR, see Minkler and Wallerstein (2008). At a minimum, each applicant must:

  • Focus on research issues of significance to a community that is interested in the proposed work.
  • Identify the role of community members in the proposed research plan (i.e., the degree of community input or engagement in the conceptualization, design, methods, analyses, or dissemination of research).
  • Describe how this research will enhance the capacity of the community.
  • Include resources for partnership development (e.g., to hire community liaisons or to provide participant support costs for community involvement).
  • If a host organization (any organization/institution other than the applicant) is used to facilitate community participation or partnerships, evaluate the organization’s mission and practices concerning community partnerships (e.g., how the staff has or can develop skills to sustain community participation).
  • Determine how to disseminate research findings to the identified community as well as the scientific community.
  • Provide evidence of community support.

E. References
Adler, N.E., Boyce, T., Chesney, M.A., Cohen, S., Folkman, S., Kahn, R.L., & Syme, S.L. (1994). “Socioeconomic status and health: The challenge of the gradient.”American Psychologist, 49(1): 15-24.

Bellinger, D.C., Leviton, A., Waternaux, C., Needleman, H., & Rabinowitz, M. (1988) “Low-level lead exposure, social class, and infant development.” Neurotoxicology and Teratology, Vol. 10: 497-503.

Calder, C.A., Holloman, C.H., Bortnick, S.M., Strauss, W., & Morara, M. (2008). “Relating Ambient Particulate Matter Concentration Levels to Mortality Using an Exposure Simulator.” Journal of the American Statistical Association, Vol. 103: 137-148.

Clougherty, J.E., J.I. Levy, L.D. Kubzansky, P.B. Ryan, S.F. Suglia, M.J. Canner, & Wright, R.J. ((2007). “Synergistic Effects of traffic-related air pollution and exposure to violence on urban asthma etiology.” Environmental Health Perspectives 115(8): 1140-1146.

Guilarte, T.R., Toscano, C.D., McGlothan, J.L., & Weaver, S.A. (2003). “Environmental enrichment reverses cognitive and molecular deficits induced by developmental lead exposure.” Annals of Neurology, Jan;53(1):50-6.

Harris, S., Sass-Kortsak, A., Corey, P., & Purdham, J. (2002). “Development of models to predict dose of pesticides in professional turf applicators.”  Journal of Exposure Analysis and Environmental Epidemiology, 12, 130–144.

Israel, B.A., Schulz, J., Parker, E.A., & Becker, A.B. (2001). "Community-Based Participatory Research: Policy Recommendations for Promoting a Partnership Approach in Health Research." Education for Health 14(2): 182-197.
Kawachi, I., & Berkman, L., Eds. (2003). Neighborhoods and Health. Oxford University Press, New York.

Krieger,  N. (2007). “Why epidemiologists cannot afford to ignore poverty.” Epidemiology,18(6):658-63.

Minkler, M. & Wallerstein, N., Eds. (2008). Community-Based Participatory Research for Health: From Process to Outcomes, 2nd Ed. Jossey-Bass Publishers, New York.

Morello-Frosch, R. & Shenassa, E. D. (2006). “The Environmental Riskscape and Social Inequality: Implications for Explaining Maternal and Child Health Disparities.” Environmental Health Perspectives, 114(8): 1150-1153.

Rauh, V.A., Whyatt R.M., Garfinkel, R., Andrews, H., Hoepner L., Reyes, A. Diaz, D., Camann D., & Perera, F.P. (2004). “Developmental effects of exposure to environmental tobacco smoke and material hardship among inner-city children.” Neurotoxicological Teratology, May-June; 26(3):373-85, 2004.

Schneider, J.S., Lee, M.H., Anderson, D.W., Zuck, L., & Lidsky, T.I. (2001). “Enriched environment during development is protective against lead-induced neurotoxicity.” Brain Research, 896(1-2):48-55.

Virgolini, M.B., Bauter, M.R., Weston, D.D., & Cory-Slechta, D.A. (2006). “Permanent alterations in stress responsivity in female offspring subjected to combined maternal lead exposure and/or stress.” Neurotoxicology, 27(1):11-21.

Weiss, B. & Bellinger, D.C. (2006).Social ecology of children’s vulnerability to environmental pollutants.” Environmental Health Perspectives, 114(10): 1479-1485.

Reports
National Research Council. Science and Judgment in Risk Assessment. Washington, DC: National Academy Press, 1994.

National Research Council. Models in Environmental Regulatory Decision Making. Committee on Models in the Regulatory Decision Process. Washington, DC: National Academy Press, 2007.

Presidential/Congressional Commission on Risk Assessment and Risk Management. Risk Assessment and Risk Management in Regulatory Decision-Making. Washington, DC, 1997.

U.S. EPA (2003). Framework for Cumulative Risk Assessment, EPA/630/P-02/001F). Risk Assessment Forum. Washington, DC, 2003. Available at http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=54944.

U.S. EPA. (2004). Ensuring Risk Reduction in Communities with Multiple Stressors: Environmental Justice and Cumulative Risks/Impacts.  National Environmental Justice Advisory Committee. Washington, DC. Available online at www.epa.gov/compliance/resources/publications/ej/nejac/nejac-cum-risk-rpt-122104.pdf.

U.S. EPA. (2007). Concepts, Methods, and Data Sources for Cumulative Health Risk Assessment of Multiple Chemicals, Exposures and Effects: A Resource Document (Final Report). U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-06/013F.

U.S. EPA. (2007). Workshop on Research Needs for Community-Based Risk Assessment: Workshop Proceedings. Office of Research and Development. Washington, DC. Available online at http://www.epa.gov/ncer/ehs/presentations/11_18_07/proceedings.pdf.

U.S. EPA. (2009). New Approaches and Tools for the Conduct of Community-Based Cumulative Risk Assessments. Human Exposure and Atmospheric Sciences Division. Available online at http://www.epa.gov/heasd/risk/projects/c3a_risk_assessment_tools.htm.

Statutes
U.S. 104th Congress. (1996a) Food Quality Protection Act (FQPA). PL 104-170. Available online at http://www.epa.gov/pesticides/regulating/laws/fqpa/.

F. Special Requirements
Agency policy prevents EPA technical staff and managers from providing individual applicants with information that may create an unfair competitive advantage. Consequently, EPA employees will not review, comment, advise, and/or provide technical assistance to applicants preparing applications in response to EPA RFAs, nor will they endorse an application or discuss in any manner how the Agency will apply the published evaluation criteria for this competition.

Multiple Investigator applications may be submitted as: (1) a single Lead Principal Investigator (PI) application with Co-PI(s) or (2) a Multiple PI application (with a single Contact PI). If you choose to submit a Multiple PI application, you must follow the specific instructions provided in Sections IV. and V. of this RFA. For further information, please see the EPA Implementation Plan for Policy on Multiple Principal Investigators (http://rbm.nih.gov/toolkit.htm).

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 subawardees of the recipient.

The application must include a plan (see Data Plan in section IV.B.5.c.) to make available to the public and community partners 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.

These awards may involve the collection of Geospatial Information, which includes information that identifies the geographic location and characteristics of natural or constructed features or boundaries on the Earth or applications, tools, and hardware associated with the generation, maintenance, or distribution of such information. This information may be derived from, among other things, a Geographic Positioning System (GPS), remote sensing, mapping, charting, and surveying technologies, or statistical data.

II. AWARD INFORMATION

It is anticipated that a total of approximately $8 million will be awarded under this announcement, depending on the availability of funds and quality of applications received.  The EPA anticipates funding approximately 9 awards under this RFA.  Requests for amounts in excess of a total of $750,000 for STAR-E1 and $1,250,000 for STAR-E2, including direct and indirect costs, will not be considered.  The total project period requested in an application submitted for this RFA may not exceed 4 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 to make additional awards under this announcement, consistent with Agency policy, if additional funding becomes available after the original selections are made.  Any additional selections for awards will be made no later than six months after the original selection decisions.

EPA may award 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 may award 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 may 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, located at 2 CFR Part 230. 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 Agencys 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 William Stelz (stelz.william@epa.gov) in NCER, phone (202) 343-9802.

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 Grants.gov (see Section IV.E. “Submission Instructions and Other Submission Requirements” for further information, or through any authorized alternate submission methods described in Section IV) 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.

There are two distinct areas of research covered by this solicitation. Responsive applications must propose to do one of the following:

  • STAR-E1: Develop analytic techniques to characterize effects and health risks at the community and individual levels; synthesize information from multiple datasets; extrapolate data among datasets and/or across communities; develop quantitative functions relating a health outcome to levels of multiple stressors; and characterize the uncertainty and/or limitations associated with these studies.
  • STAR-E2: Evaluate the combined effects of nonchemical and chemical stressors.

For STAR-E1, the focus must be on exposures to one of the following: (1) multiple chemicals, (2) a chemical and a nonchemical stressor together, (3) multiple chemicals and a non-chemical stressor, (4) a chemical and multiple nonchemical stressors, or (5) multiple chemicals and multiple nonchemical stressors. In addition, for all developed tools, models or approaches, uncertainties and/or limitations must be characterized. The use of existing datasets is acceptable, but not required.

Research responsive to STAR-E1 must develop tools, models or approaches to accomplish at least one of the following:

  • Integrate research results and information from multiple studies, multiple data sources, and across multiple scales of time and/or space to address various components within cumulative risk assessment.
  • Determine dose/concentration-response curves when multiple stressors exist.
  • Develop metrics or methodologies for assessing and integrating the cumulative effects of multiple sources of stress, including quantitative and qualitative indicators of nonchemical sources of stress.

 Research responsive to STAR-E2 must accomplish at least one of the following:

  • Determine the biological impact of psychosocial stress and its interaction with chemical exposures, including mechanisms of actions and the resulting health consequences. This may consider exposure influences, such as sequence and timing. It might also consider lifestage.
  • Develop dose response models for combined exposures to chemical and nonchemical stressors. Effects of timing of the exposures may be considered if appropriate.
  • Incorporate psychosocial stress into chemical or class-specific PBPK and PBPD models.
  • Identify which nonchemical stressors exacerbate chemical for particular populations or life stages.

A CBPR plan will be required for each proposed project. Although a range of levels of community involvement can be considered CBPR, CBPR is characterized by substantial community input in the project. In the application, the applicant will need to justify the level of community involvement that he or she has proposed. For additional information on CBPR, see Minkler and Wallerstein (2008). At a minimum, each applicant must:

  • Focus on research issues of significance to a community that is interested in the proposed work.
  • Identify the role of community members in the proposed research plan (i.e., the degree of community input or engagement in the conceptualization, design, methods, analyses, or dissemination of research).
  • Describe how this research will enhance the capacity of the community.
  • Include resources for partnership development (e.g., to hire community liaisons or to provide participant support costs for community involvement).
  • If a host organization (any organization/institution other than the applicant) is used to facilitate community participation or partnerships, evaluate the organization’s mission and practices concerning community partnerships (e.g., how the staff has or can develop skills to sustain community participation).
  • Determine how to disseminate research findings to the identified community as well as the scientific community.
  • Provide evidence of community support.

In addition, 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 depending on which statute(s) is listed in I.C. above.  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

Formal instructions for submission through Grants.gov follow in Section E.

A. Internet Address to Request Application Package
Use the application package available at Grants.gov (see Section E. “Submission Instructions and Other Submission Requirements”).  Note: With the exception of the budget form and the current and pending support form (available at http://www.epa.gov/ncer/RFA/forms), all necessary forms are included in the electronic application package.

An email will be sent by NCER to the Lead/Contact PI 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 Section E. “Submission Instructions and Other Submission Requirements” for additional information regarding the application receipt acknowledgment.

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

  1. Standard Form 424

    The applicant must complete Standard Form 424. 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 electronic signature of an authorized representative of the applying organization.

    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, does not apply to the Office of Research and Development's research and training programs unless EPA has determined that the activities that will be carried out under the applicants' proposal (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.

    If EPA determines that Executive Order 12372 applies to an applicant's proposal, the applicant must follow the procedures in 40 CFR Part 29. The applicant must notify their state's single point of contact (SPOC). To determine whether their state participates in this process, and how to comply, applicants should consult http://www.whitehouse.gov/omb/grants/spoc.html. If an applicant is in a State that does not have a SPOC, or the State has not selected research and development grants for intergovernmental review, the applicant must notify directly affected State, area wide, regional and local entities of its proposal.

    EPA will notify the successful applicant(s) if Executive Order 12372 applies to its proposal prior to award.

  2. Key Contacts

    The applicant must complete the Key Contacts form found in the Grants.gov application package. An Additional Key Contacts form 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 investigators). Please make certain that all contact information is accurate.

    For Multiple PI applications: The Additional Key Contacts form must be completed (see Section I.F. for further information). Note: The Contact PI must be affiliated with the institution submitting the application. EPA will direct all communications related to scientific, technical, and budgetary aspects of the project to the Contact PI; however, any information regarding an application will be shared with any PI upon request. The Contact PI is to be listed on the Key Contact Form as the Project Manager/Principal Investigator (the term Project Manager is used on the Grants.gov form, the term Principal Investigator is used on the form located on NCERs web site). For additional PIs, complete the Major Co-Investigator fields and identify PI status next to the name (e.g., Name: John Smith, Principal Investigator).

  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: For applications with multiple investigators, state whether this is a single Lead PI (with co-PIs) or Multiple PI application (see Section I.F.). For Lead PI applications, list the Lead PI, then the name(s) of each co-PI who will significantly contribute to the project. For Multiple PI applications, list the Contact PI, then the name(s) of each additional PI. 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. Research Plan, Quality Assurance Statement, Data Plan, References, and Community-Based Participatory Research Plan
    1. Research Plan (15 pages)

      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.
      2. Approach/Activities: Outline the research design, methods, and techniques that you intend to use in meeting the objectives stated above.
      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 publics ability to protect the environment and human health. A clear, concise description will help NCER and peer reviewers understand the merits of the research.
      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.
      5. Appendices may be included but must remain within the 15-page limit.
    2. Quality Assurance Statement (3 pages)

      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.

      NOTE: If selected for award, applicants will be expected to provide additional quality assurance documentation.

      Address each applicable 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. (Not all will apply.)

      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 persons functions, experience, and authority within the research organization. Describe the organizations 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. Identify the types of secondary data needed to satisfy the project objectives. Specify requirements relating to the type of data, the age of data, geographical representation, temporal representation, and technological representation, as applicable.
          2. Specify the source(s) of the secondary data and discuss the rationale for selection.
          3. Establish a plan to identify the sources of the secondary data in all deliverables/products.
          4. Specify quality requirements and discuss the appropriateness for their intended use. Accuracy, precision, representativeness, completeness, and comparability need to be addressed, if applicable.
          5. Describe the procedures for determining the quality of the secondary data.
          6. Describe the plan for data management/integrity.
        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 methods 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.
    3. Data Plan (2 pages)

      Provide 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 as well as community partners. 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 other page limits (e.g. research plan, quality assurance statement, data plan)
    5. Community-Based Participatory Research Plan (3-5 pages)

      Provide a plan to detail community involvement. Different levels of community involvement are acceptable, however, the applicant must justify the level selected for his/her particular research project. In the plan for community involvement, the applicant must demonstrate that, at a minimum, he/she will:

      • Focus on research issues of significance to a community that is interested in the proposed work.
      • Identify the role of community members in the proposed research plan (i.e., the degree of community input or engagement in the conceptualization, design, methods, analyses, or dissemination of research).
      • Describe how this research will enhance the capacity of the community.
      • Include resources for partnership development (e.g., to hire community liaisons or to provide participant support costs for community involvement).
      • If a host organization (any organization/institution other than the applicant) is used to facilitate community participation or partnerships, evaluate the organizations mission and practices concerning community partnerships (e.g., how the staff has or can develop skills to sustain community participation).
      • Determine how to disseminate research findings to the identified community as well as the scientific community.
      • Provide evidence of community support.
  6. 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. Note: The budget table should be attached to the Project Narrative Attachment Form electronic file [see Section IV.E.3.(d) Project Narrative Attachment Form]. If a subaward, such as a subagreement with an educational institution 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. Applicants may not use subagreements to transfer or delegate their responsibility for successful completion of their EPA assistance agreement. Therefore, EPA expects that subawards or subcontracts should not constitute more than 40% of the total direct cost of the total project budget. If a subaward/subcontract constitutes more than 40% of the total direct cost, additional justification may be required before award, 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.

      Please note that when formulating budgets for proposals/applications, applicants must not include management fees or similar charges in excess of the direct costs and indirect costs at the rate approved by the applicants cognizant audit agency, or at the rate provided for by the terms of the agreement negotiated with EPA. The term "management fees or similar charges" refers to expenses added to the direct costs in order to accumulate and reserve funds for ongoing business expenses, unforeseen liabilities, or for other similar costs that are not allowable under EPA assistance agreements. Management fees or similar charges may not be used to improve or expand the project funded under this agreement, except to the extent authorized as a direct cost of carrying out the scope of work.

    2. Budget Justification [2 pages in addition to the Section IV.B.5. 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 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 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.
  7. 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.

  8. 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 current and pending research regardless of source.

  9. 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 the success of the proposal are considered letters of support. Letters of support, and letters of intent that exceed one brief paragraph (excluding letterhead and salutations), 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. Any transactions between the successful applicant and parties providing letters of support or intent financed with EPA grant funds are subject to the funding restrictions described in Section IV. D.

    2. Funding Opportunity Number(s) (FON)

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

      Applicants must select the FON corresponding to their proposed research topic area. It is the responsibility of the applicant to identify the proper FON based on the nature of the proposed research. Failure to do so could result in an inappropriate peer review assignment. If your research seems to fit under more than one FON, choose the most appropriate one. Each application must be submitted using a single FON.

      The Funding Opportunity Numbers for this RFA are:

        Developing Statistical and Other Analytical Techniques for Cumulative Risk Assessments, EPA-G2009-STAR-E1
        Evaluating the Interaction of Nonchemical and Chemical Stressors, EPA-G2009-STAR-E2
    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 their application/proposal package as confidential business information. EPA will evaluate confidentiality claims in accordance with 40 CFR Part 2. Applicants must clearly mark applications/proposals or portions thereof that they claim as confidential. If no claim of confidentiality is made, EPA is not required to make the inquiry to the applicant otherwise required by 40 CFR 2.204(c)(2) prior to disclosure. However, competitive proposals/applications are considered confidential and protected from disclosure prior to the completion of the competitive selection process.

C. Submission Dates and Times
Applications must be transferred to Grants.gov no later than 4:00 pm Eastern Time on the solicitation closing date.  Applications transferred 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 solicitation closing date, a new date will be posted on the NCER web site (http://www.epa.gov/ncer/) and a modification posted on www.grants.gov.

Solicitation Closing Date: June 17, 2009, 4:00 pm Eastern Time (applications must be submitted to Grants.gov by this time, see Section IV.E “Submission Instructions and Other Submission Requirements” for further information).

NOTE: Customarily, applicants are notified about evaluation decisions within six months of the solicitation closing date.  Awards are generally made 9-12 months after the solicitation closing date.

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(s).

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.

EPA awards funds to one eligible applicant as the recipient even if other eligible applicants are named as partners or co-applicants or members of a coalition or consortium. The recipient is accountable to EPA for the proper expenditure of funds.

Funding may be used to provide subgrants or subawards of financial assistance, which includes using subawards or subgrants to fund partnerships, provided the recipient complies with applicable requirements for subawards or subgrants including those contained in 40 CFR Parts 30 or 31, as appropriate. Applicants must compete contracts for services and products, including consultant contracts, and conduct cost and price analyses to the extent required by the procurement provisions of the regulations at 40 CFR Parts 30 or 31, as appropriate. The regulations also contain limitations on consultant compensation. Applicants are not required to identify subawardees/subgrantees and/or contractors (including consultants) in their proposal/application. However, if they do, the fact that an applicant selected for award has named a specific subawardee/subgrantee, contractor, or consultant in the proposal/application EPA selects for funding does not relieve the applicant of its obligations to comply with subaward/subgrant and/or competitive procurement requirements as appropriate. Please note that applicants may not award sole source contracts to consulting, engineering or other firms assisting applicants with the proposal based solely on the firm's role in preparing the proposal/application.

Successful applicants cannot use subgrants or subawards to avoid requirements in EPA grant regulations for competitive procurement by using these instruments to acquire commercial services or products from for-profit organizations to carry out its assistance agreement. The nature of the transaction between the recipient and the subawardee or subgrantee must be consistent with the standards for distinguishing between vendor transactions and subrecipient assistance under Subpart B Section .210 of OMB Circular A-133, and the definitions of subaward at 40 CFR 30.2(ff) or subgrant at 40 CFR 31.3, as applicable. EPA will not be a party to these transactions. Applicants acquiring commercial goods or services must comply with the competitive procurement standards in 40 CFR Part 30 or 40 CFR Part 31.36 and cannot use a subaward/subgrant as the funding mechanism. Section V of the announcement describes the evaluation criteria and evaluation process that will be used by EPA to make selections under this announcement. During this evaluation, except for those criteria that relate to the applicant's own qualifications, past performance, and reporting history, the review panel will consider, if appropriate and relevant, the qualifications, expertise, and experience of: (i) an applicant's named subawardees/subgrantees identified in the proposal/application if the applicant demonstrates in the proposal/application that if it receives an award that the subaward/subgrant will be properly awarded consistent with the applicable regulations in 40 CFR Parts 30 or 31. For example, applicants must not use subawards/subgrants to obtain commercial services or products from for profit firms or individual consultants. (ii) an applicant's named contractor(s), including consultants, identified in the proposal/application if the applicant demonstrates in its proposal/application that the contractor(s) was selected in compliance with the competitive procurement standards in 40 CFR Part 30 or 40 CFR 31.36 as appropriate. For example, an applicant must demonstrate that it selected the contractor(s) competitively or that a proper non-competitive sole-source award consistent with the regulations will be made to the contractor(s), that efforts were made to provide small and disadvantaged businesses with opportunities to compete, and that some form of cost or price analysis was conducted. EPA may not accept sole source justifications for contracts for services or products that are otherwise readily available in the commercial marketplace. EPA will not consider the qualifications, experience, and expertise of named subawardees/subgrantees and/or named contractor(s) during the proposal/application evaluation process unless the applicant complies with these requirements. 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
Please read this entire section before attempting an electronic submission through Grants.gov.

If you do not have the technical capability to utilize the Grants.gov application submission process for this solicitation, call 1-800-490-9194 or send a webmail message to http://www.epa.gov/ncer/contact_us.html at least 15 calendar working days before the submission deadline to assure timely receipt of alternate submission instructions. In your message provide the funding opportunity number and title of the program, specify that you are requesting alternate submission instructions, and provide a telephone number, fax number, and an email address, if available. Alternate instructions will be e-mailed whenever possible. Any applications submitted through alternate submission methods must comply with all the provisions of this RFA, including Section IV, and be received by the solicitation closing date identified above.

Note: Grants.gov submission instructions are updated on an as-needed basis. Please provide your Authorized Organizational Representative (AOR) with a copy of the following instructions to avoid submission delays that may occur from the use of outdated instructions.

  1. Preparing for Submission. The appropriate electronic application package available through the Grants.gov site must be used for electronic submissions. To begin the application process, go to http://www.grants.gov and click on the Apply for Grants tab on the left side of the page. Then click on Apply Step 1: Download a Grant Application Package to download the compatible Adobe viewer and obtain the application package. (Note: The PureEdge viewer is not needed to submit an application to this funding opportunity.) For more information on Adobe Reader please go to http://www.grants.gov/help/help.jsp.

    Note:Grants.gov is aware of a corruption issue when Adobe Reader application packages are saved in different versions of Adobe Reader. It is recommended that applicants uninstall earlier versions of Adobe Reader and then install the version available and compatible through Grants.gov.

    The application package may be quickly accessed from https://apply07.grants.gov/apply/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. Note: With the exception of the budget form and the current and pending support form (available at http://www.epa.gov/ncer/rfa/forms), all necessary forms are included in the electronic application package.

    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. 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. Note for organizations not currently registered: the registration process may take a week or longer to complete. We recommend you designate an AOR and begin the registration process as soon as possible.

    For more information, go to http://www.grants.gov and click on Get Registered.

  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 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 Lead/Contact PI and the Administrative Contact. This email will be sent from receipt.application@epa.gov; emails 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 a. though d. below.
    1. On the initial electronic Grant Application Package page, complete the Application Filing Name field by entering the Lead/Contact PIs 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 (d) below.
    4. Project Narrative Attachment Form (click on Add Mandatory Project Narrative): Attach a single electronic file labeled Application that contains the items described in Section IV.B.3. through IV.B.9.a (Table of Contents, Abstract, Research Plan, Quality Assurance Statement, Data Plan, References, Community-Based Participatory Research Plan, Budget and Budget Justification, Resumes, Current and Pending Support, and Letters of Intent/Support) of this solicitation. In order to maintain format integrity, 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 Table of Contents (Section IV.B.3.).

    Once the application package has been completed, the Submit button should be enabled. If the Submit button is not active, please call Grants.gov for assistance at 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 or a revised application needs to be submitted. Note: Revised applications must be submitted before the solicitation closing date and time.

  4. Submitting the application. 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, including contacting Grants.gov, 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 or screen capture this acknowledgement. If a submission problem occurs, reboot the computer turning the power off may be necessary and re-attempt the submission. If submission problems continue, call Grants.gov for assistance (Telephone: 1-800-518-4726).

    Note: Grants.gov issues a case number upon a request for assistance.

  5. Transmission Difficulties. If transmission difficulties that result in a late transmission, no transmission, or rejection of the transmitted application are experienced, and following the above instructions do not resolve the problem so that the application is submitted to Grants.Gov by the deadline date and time, follow the guidance below. NCER may decide to review the application if it is clearly demonstrated that transmission difficulties were due solely as a result of problems associated with the transfer to Grants.gov and documentation that these instructions were followed is provided. 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 Ron Josephson 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 5:00 pm Eastern Time on the solicitation closing date, send an e-mail before 5:00 pm Eastern Time on the deadline date. The email must document the problem and include the Grants.gov case number.
    2. Unsuccessful transfer of the application package: If a successful transfer of the application cannot be accomplished even with assistance from Grants.gov due to electronic submission issues, send an email before 5:00 pm Eastern Time on the solicitation closing date. The email must document the problem, include the Grants.gov case number, and attach the entire application.
    3. Grants.gov rejection of the application package: If a notification is received from Grants.gov stating that the application has been rejected for reasons other than late submittal, promptly send an email that includes any materials provided by Grants.gov and attach the entire application.

V. APPLICATION REVIEW INFORMATION

A. Peer Review
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 applications merit based on the criteria below. Criteria 1-6 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. Practical and technically defensible approach that can be performed within the proposed time period.
    3. Research contributes to scientific knowledge in the topic area.
    4. Projected benefits of the proposed activity to society, such as improving the environment or human health.
    5. The results are disseminated broadly to enhance scientific and technological understanding.
    6. The proposal is 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. All key personnel must make a significant time commitment to the project.
  3. Community-Based Participatory Research (CBPR) Plan: This criterion will be evaluated based on the following: Demonstration that the focus is on research issues of significance to a community that is interested in the proposed work and that the role of the community members is appropriate for the research; the ability of the research to enhance community capacity; the plan for disseminating research findings to the community; if a host organization is used to facilitate community participation, evaluation of the organizations community partnership mission and practices; and evidence of community support.
  4. Responsiveness: The responsiveness of the proposal to the research needs identified for the research area. The proposal adequately addresses the objectives and special considerations specified by the RFA.
  5. Facilities and equipment: The availability and/or adequacy of the facilities and equipment proposed for the project. Note any deficiencies that may interfere with the successful completion of the research.
  6. Budget: Although budget information does not reflect on the applications 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.

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 PIs (in the case of Multiple-PI applications, the Contact PIs) "Past Performance and Reporting History." The applicant must provide the EPA Project Officer with information on the proposed Lead/Contact PI's past performance and reporting history under prior Federal agency assistance agreements (assistance agreements include grants and cooperative agreements but not contracts) 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/Contact 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 three 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/Contact 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/Contact PI's past performance [under Federal agency assistance agreements (assistance agreements include grants and cooperative agreements but not contracts) 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/Contact 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/Contact 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.

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 and available funds. Applicants selected for funding will be required to provide additional information listed below under Award Notices. The application will then be forwarded to EPAs Grants and Interagency Agreement Management Division for award in accordance with the EPAs procedures.

VI. AWARD ADMINISTRATION INFORMATION

A. Award Notices
Customarily, applicants are notified about evaluation decisions within six months of the solicitation 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 the Lead PI/Contact PI to obtain these materials. Before or after an award, applicants may be required to provide additional quality assurance documentation.

Non-profit applicants that are recommended for funding under this announcement are subject to pre-award administrative capability reviews consistent with Sections 8b., 8c. and 9d. of EPA Order 5700.8 - Policy on Assessing Capabilities of Non-Profit Applicants for Managing Assistance Awards (http://www.epa.gov/ogd/grants/award/5700_8.pdf (PDF) (9 pp, 31 K)). In addition, non-profit applicants that qualify for funding may, depending on the size of the award, be required to fill out and submit to the Grants Management Office the Administrative Capabilities Form with supporting documents contained in Appendix A of EPA Order 5700.8.

The official notification of an award will be made by the Agencys Grants and Interagency Agreement Management 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: Principal Investigators will be expected to budget for, and participate in, All-Investigators Meetings (also known as progress reviews) approximately once per year with EPA scientists and other grantees to report on research activities and discuss issues of mutual interest.
  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 CFR § 26. Studies involving intentional exposure of human subjects who are children or pregnant or nursing women are prohibited by Subpart B of 40 CFR § 26. For observational studies involving children or pregnant women and fetuses please refer to Subparts C & D of 40 CFR § 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." EPAs regulation 40 CFR § 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 applicants 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/exmural.html#genreqts. 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 located at 2 CFR Part 215 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 NCERs 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: EPAs 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.

  8. Exchange Network: EPA, states, territories, and tribes are working together to develop the National Environmental Information Exchange Network, a secure, Internet- and standards-based way to support electronic data reporting, sharing, and integration of both regulatory and non-regulatory environmental data. States, tribes and territories exchanging data with each other or with EPA, should make the Exchange Network and the Agency's connection to it, the Central Data Exchange (CDX), the standard way they exchange data and should phase out any legacy methods they have been using. More information on the Exchange Network is available at www.exchangenetwork.net.

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: William Stelz (stelz.william@epa.gov); phone: 703-347-8039
Electronic Submissions: Ron Josephson (josephson.ron@epa.gov); phone: 703-308-0442
Technical Contact: Deborah Segal (segal.deborah@epa.gov); phone: 703-347-8528

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