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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

Exploring Linkages Between Health Outcomes and Environmental Hazards, Exposures, and Interventions for Public Health Tracking and Risk Management

This is the initial announcement of this funding opportunity.

Funding Opportunity Number:

    Exploring Linkages between Health Outcomes and Environmental Hazards, Exposures, and Interventions for Public Health Tracking and Risk Management: EPA-G2009-STAR-B1
    Early Career Projects: Exploring Linkages between Health Outcomes and Environmental Hazards, Exposures, and Interventions for Public Health Tracking and Risk Management: EPA-G2009-STAR-B2

Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: May 7, 2009
Solicitation Closing Date: August 5, 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: Maggie Breville (breville.maggie@epa.gov); phone: 703-347-8050

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 to develop new or improved environmental public health indicators (EPHIs) to build linkages between environmental hazards, human exposures, and public health outcomes. The aim of the research is to develop indicators that can be used for long-term tracking and surveillance of environmental public health, making better informed decisions, and assessing the actual impacts of environmental risk management decisions. Proposed projects should capitalize on existing knowledge bases, data sources, or cohorts to develop EPHIs that reflect a better understanding of the relationships between environmental conditions, human exposure, and/or public health outcomes. Novel application of statistical methods or models may be needed to establish probable relationships between existing datasets or investigate the consequences of environmental actions and policy changes.

Award Information:
Anticipated Type of Award: Grant or cooperative agreement
Estimated Number of Awards: Approximately 5 regular awards, 2 early career awards (See Section III for more information)
Anticipated Funding Amount: Approximately $3 million total for all awards
Potential Funding per Award: For a regular award, up to a total of $500,000, including direct and indirect costs, with a maximum duration of 3 years. Early career awards are limited to a total of $250,000, including direct and indirect costs, with duration of 3 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. Special eligibility criteria apply to the early career project portion of this RFA. See full announcement for more details.

Application Materials:
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/. Electronic submission of your application must be performed by an authorized representative of your organization.

Applicants must submit the full application in PDF format via electronic mail to

2009-EPHI-APPS@epa.gov with the funding opportunity number (FON) in the subject line.

If you do not have the technical capability to utilize the electronic mail 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 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 submitted by the solicitation closing date and time 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: Maggie Breville (breville.maggie@epa.gov); phone: 703-347-8050

I. FUNDING OPPORTUNITY DESCRIPTION

A. Introduction
Environmental factors play a significant role in the health of communities. Adults and children can be exposed to a wide variety of contaminants in food, water, air, and through everyday activities. However, there are a limited number of environmental contaminants that have been clearly associated with human disease. Among the examples are the associations between radon gas and lung cancer (Field et. al., 2000); asbestos and respiratory cancers (ATSDR, 2001); lead exposure and nervous system disorders (Goyer, 1993); and ozone and short-term respiratory effects (EPA, 2006). Based on these recognized relationships, relevant exposures or health outcomes can be tracked and actions can be taken to protect public health. There are many other suspected links between environmental exposures and health effects that have not been characterized well enough to provide indicators for public health tracking. Recent observed effects in wildlife and laboratory animals suggest that newly recognized or emerging contaminants have the potential for human exposure and health impacts. Examples include disinfection byproducts, endocrine disruptors, flame retardants, plasticizers, persistent organic pollutants, polyfluoroalkyl chemicals, parabens, phthalates, antimicrobials, pesticides, ultrafine particulates, toxic air pollutants, nanomaterials, water-borne pathogens, and pharmaceuticals. The combined impact of mixtures of low levels of contaminants is also of concern and research is currently underway to better understand sources, exposure, and health outcomes associated with these contaminants, as well as exposure to multiple stressors.

Environmental monitoring programs and public health tracking programs are both limited by not knowing which indicators are most important to measure and track. The data from these types of programs are rarely able to effectively link changes in contaminant levels over time to impacts on public health. Research is needed to understand the associations between the data on sources of environmental contaminants, environmental quality, levels present in the human body, and/or the cumulative effects on health and disease status. With indicators based on a better understanding of these relationships, inherent variability across time, geographic location and population, environmental health disparities, and impacts on large populations can be investigated.

Environmental professionals in industry, communities, and at all levels of government take actions to protect the public health from exposure to environmental contaminants. Local-, regional-, state- and national-level policies on consumer protection, industrial and municipal discharges, water, and air quality are intended to control known or suspected routes of human exposure and therefore, protect public health. Actions such as implementing limits on levels of pollutants in the environment, limiting pollutant releases, permitting the use of industrial processes, and educating the public on reducing exposures are taken to protect or improve health. In most cases, environmental statutes do not require conclusive proof of a relationship between exposure to an environmental contaminant and a health outcome before action can be taken. However, environmental health managers are often asked whether changes in environmental policies produce demonstrable improvements in public health outcomes. The development and adoption of EPHIs into surveillance programs can be used to complement traditional hazard indicators such as changes in emissions, discharges, and pollutant levels in environmental media, and can be valuable in demonstrating effectiveness of environmental management programs. These indicators could then be used to understand and monitor overall trends in population exposure, health, and disease, including trends across different age, gender, race, and ethnic groups. Over time, use of environmental public health indicators can lead to better informed risk management actions.

In addition to regular awards, this solicitation includes the opportunity for early career projects. Please see Section III of this Request for Applications (RFA) for details on the early career eligibility criteria.

B. Background
An indicator provides an easily interpretable measure of the state of the environment or the health of a particular population. Indicators have been used for public health surveillance for a long time and there are several recent reports on using them for environmental health tracking. According to the Center for Disease Control and Prevention (CDC), an environmental public health indicator “provides information about a population’s health status with respect to environmental factors. It can be used to assess health or a factor associated with health in a specified population through direct or indirect measures” (CDC, 2006 exit EPA). A proposed framework for environmental public health surveillance (Thacker et. al., 1996) discusses specific issues such as using a combination of hazard, exposure, and outcome indicator data from different sources. The authors stress the need for environmental health professionals to work together with occupational and public health professionals to identify the most important health outcome and exposure indicators.

Understanding the impact of environmental decisions on human health and measuring actual progress toward stated environmental goals requires linking hazard indicators (e.g. air emissions, discharges to water bodies, or pollutant levels in soils or sediments) with exposures and effects on human health. Traditionally, the progress or success of environmental programs is tracked by monitoring these types of hazard indicators. Most environmental data collection by federal and state environmental agencies is collected for regulatory purposes under the Clean Air Act, Clean Water Act, and Safe Drinking Water Act. Examples of environmental data include criteria air pollutant ambient monitoring data (ozone, sulfur dioxide, particulate matter) Air Quality System (AQS; http://www.epa.gov/ttn/airs/airsaqs/), national and state pesticide exposure surveillance programs (http://www.cdc.gov/niosh/topics/pesticides/), the Safe Drinking Water Information System (SDWIS; http://www.epa.gov/enviro/html/sdwis/), and the Toxic Release Inventory (TRI; http://www.epa.gov/tri/). Although national and regional programs are in place to monitor or track environmental hazards in air, water, and food, these measurements alone cannot reveal whether or how much of the contaminants have contacted or entered people's bodies or whether health effects have occurred. Data collection is ongoing in biomonitoring programs such as the CDC’s National Health and Nutrition Examinations Survey (NHANES) to measure levels of contaminants present in human tissues. Since 2006, the National Institute of Environmental Health Sciences (NIEHS) has supported grant research on the development of technologies to improve exposure assessment methods and new datasets may be available. Modeling efforts have also estimated exposure according to human activities and location of jobs or residences.

Some potential uses for environmental public health indicators include:

  • Surveillance – public health tracking
  • Development and testing of epidemiological research hypotheses
  • Public health policy and decision-making
  • Environmental health management
  • Environmental health program development
  • Accountability for environmental actions

In 2003, EPA published a report on America’s Children and the Environment (http://www.epa.gov/envirohealth/children/) presenting trends in levels of environmental contaminants in air, water, food, and soil; concentrations of contaminants measured in the bodies of mothers and children; and childhood diseases that may be influenced by environmental factors. The indicators are based on national data sets collected and maintained by EPA, CDC and other Federal agencies.  Recent online updates to the report have extended the time series data. Some important children’s environmental health issues could not be addressed in the 2003 report because of a lack of nationally representative data.  Current work involves evaluating newly emerging children’s environmental health issues and new data sets.

The EPA Environmental Indicators Initiative (http://www.epa.gov/indicators/) was launched to better assess the “state of the environment” that may result from local, state, and federal risk management decisions intended to improve environmental quality and human health. The challenge for this effort, and other initiatives, is to link national-level indicators of pollutants to actual human exposures and health outcomes. The Report on the Environment (ROE) (US EPA, 2008) represents the best available, scientifically sound information on national environmental and human health trends critical to EPA's mission and of interest to the public. The ROE describes trends in progress towards the goals of clean air, water, land, human exposure, health, and ecological condition. Additional research needs include data that allow analysis of geographic trends, examination of other diseases and conditions for which environmental contaminants may be a risk factor, and methods to integrate data from different collection systems and different scales (regional, state, local).

EPA has also developed a Framework for Assessing the Public Health Impacts of Risk Management Decisions that describes the policy needs related to risk management in the context of the source-to-exposure-to-effect risk assessment paradigm (EPA, 2008b). EPA plans to use the Framework as a guide for an integrated multidisciplinary research program to develop and validate EPHIs for assessing environmental health conditions.

Other U.S. and international efforts initiated programs to develop indicators and track environmental exposures and health outcomes. In 2000, an evaluation of the national environmental public health infrastructure sponsored by the Pew Environmental Health Commission identified fundamental information gaps in understanding the relationship between environmental hazards, human exposures, and diseases with environmental etiology (Environmental Health Project Tracking Team, 2000). A Nationwide Health Tracking Network was proposed which could identify patterns of chronic disease occurrence related to environmental factors. Recommendations included “nationwide baseline tracking of priority chronic diseases–asthma and chronic respiratory diseases; birth defects; developmental disorders; cancers; neurological diseases–and priority exposures, such as PCBs, and dioxin; heavy metals; pesticides and water and air contaminants”. The priority information and data needs for a National Environmental Public Health Tracking Program are discussed in a series of articles (McGeehin et. al., 2004; Litt et. al., 2004). The methodological challenges for using existing data for alternate purposes than intended require adapting statistical techniques to environmental public health problems (Mather et. al., 2004).

Finding improved approaches to compare or link disparate data sets is the key to the improved use of environmental public health indicators. In response to the Pew report, the CDC and the Council of State and Territorial Epidemiologist (CSTE) initiated the National Environmental Public Health Tracking System. Currently, there are no state or national level systems to track many of the exposures and health effects that may be related to environmental hazards. In addition, in most cases, existing environmental hazard, exposure, and disease tracking systems are not linked together. Because existing systems are not linked, it is difficult to study and monitor relationships among hazards, exposures, and health effects. In addition, CDC collaborated with EPA, CSTE, and the Agency for Toxic Substances and Disease Registry (ATSDR) on an environmental public health indicators (EPHI) project (CDC, 2006) to develop a common set of reliable indicators that state health departments can use to develop comprehensive environmental public health programs. The collaboration resulted in a list of proposed EPHIs (indicators of hazard, exposure, health effects, and intervention) that could be used to track chronic disease and health of populations. The CDC effort is intended to build the number of available standardized indicators to allow public health surveillance under a National Public Health Tracking Program.

The World Health Organization (WHO) aims to establish a harmonized and evidence-based system to support public health and environmental policies. Proposed model frameworks describe simplifications for complex environment-health interactions that can help to select and evaluate EPHIs in the context of risk management decisions. The DPSEEA model, or Driving Force – Pressure – State – Exposure – Effect – Action, recognizes the potential impact that policy actions can have on different points in the environment–health continuum. The Multiple Exposure-Multiple Effect (MEME) model stresses the many interactions possible between exposures and health outcomes and the contexts and actions that can influence them (WHO, 2003; http://www.who.int/phe/children/en/cehindic.pdf exit EPA). MEME models have been applied to an evaluation of children’s exposure and health outcome indicators in North America (CEC, 2006). In addition, a European Environment and Health Information System (EHIS) has been established and efforts are summarized in a 2007 report Children’s Health and the Environment in Europe: A Baseline Assessment (WHO/Europe, 2007 exit EPA).

Previous EPA grant solicitations related to the development of EPHIs include a 2004 RFA on Early Indicators of Environmentally Related Disease to develop tools that can be used as predictors of environmentally related disease. RFAs in 2006 and 2007 on Development of Environmental Health Outcome Indicators focused on developing indicators to link data at different points in the source to outcome risk assessment paradigm. A public meeting was held in January 2008 to encourage an ongoing dialogue between investigators developing EPHIs and focused on assessing risk management decisions (EPA, 2008). This RFA is a continuation of these efforts to develop new or improved EPHIs that will serve environmental public health programs.

The specific Strategic Goal and Objective from EPA’s Strategic Plan that relate to this solicitation are: Goal 4: Healthy Communities and Ecosystems, Objective 4.4: Enhance Science and Research. The EPA’s Strategic Plan can be found at 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 Water Act, Section 104, 33 U.S.C. 1254, Safe Drinking Water Act, Section 1442, 42 U.S.C. 300j-1, Toxic Substances Control Act, Section 10, 15 U.S.C. 2609, Clean Air Act, Section 103, 42 U.S.C. 7403, and Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, 7 U.S.C. 136r.

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
The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications to develop new or improved environmental public health indicators (EPHIs) to build linkages between environmental hazards, human exposures, and public health outcomes. The aim of the research is to develop indicators that can be used for long-term tracking and surveillance of environmental public health, making better informed decisions, and assessing the actual impacts of environmental risk management decisions. Proposed projects should capitalize on existing knowledge bases, data sources, or cohorts to develop EPHIs that reflect a better understanding of the relationships between environmental conditions, human exposure, and/or public health outcomes. Novel application of statistical methods or models may be needed to establish probable relationships between existing datasets or investigate the consequences of environmental actions and policy changes.

The following research areas are of interest:

  • Relationship between an environmental risk management or policy decision and changes in an environmental public health indicator. Applications that propose to investigate these relationships are of particular interest.
  • Linkage between environmental hazard, exposure, and/or outcome databases that are collected or aggregated at a similar geographic scale.
  • Relationships between contaminant levels in environmental media (e.g., air, drinking water, diet, soil) and exposure/dose biomarkers for an environmental pollutant that can be used to indicate an environmentally relevant health outcome.
  • Relationships between contaminant levels in environmental media (e.g., air, drinking water, diet, soil) and environmentally relevant health outcomes.
  • Relationships between exposure/dose biomarkers (or other exposure-related metrics) and early biological indicators of disease that can be used to indicate an environmentally relevant health outcome.

A growing number of emerging contaminants are suspected of contributing to adverse health outcomes, but further evaluation of exposure-outcome relationships is needed. Environmental contaminants of interest include, but are not limited to: disinfection byproducts, endocrine disruptors, flame retardants, plasticizers, polyfluoroalkyl chemicals, parabens, phthalates, antimicrobials, pesticides, ultrafine particulates, toxic air pollutants, nanomaterials, water-borne pathogens, pharmaceuticals, and personal care products.

Chronic diseases are now the leading causes of morbidity and mortality, but the contribution of environmental factors to chronic health effects is not well understood. Therefore, health outcomes of interest for which there are potential environmental risk factors include, but are not limited to: chronic neurodegenerative disorders, behavioral and neurodevelopmental disorders, childhood cancer, reproductive function, endocrine disorders such as diabetes, pubertal maturation, thyroid hormone effects, birth defects, adverse birth outcomes, renal disease, immune disorders, cardiovascular and respiratory effects including asthma, and abnormal developmental outcomes.

EPA encourages proposals that incorporate the following information:

  • The suitability of the selected hazard, exposure, or health data for developing and/or evaluating the proposed indicator(s);
  • The specificity of the proposed indicator to a particular geographic setting, population, or exposure scenario (e.g., unique regional and/or seasonal variations of environmental, exposure or health-related data);
  • The likelihood that the approach can connect changes in the indicator to actual changes in exposure and public health outcome or markers associated with health outcomes (early biological changes);
  • The applicability and generalizability of the expected results to other environmental circumstances;
  • An estimate of the variability and uncertainty and discussion of possible cofounders associated with the indicator;
  • The expected impact the proposed research may have on environmental public health.

The expected outputs from this research will be indicators, indices, statistical relationships and/or mathematical models that will link data on environmental hazards, human exposure, early biological changes, and/or health outcomes. The resulting indicators should be sufficiently characterized to act as surrogates of health outcomes and to allow tracking of the impact of environmental management decisions or policy changes over temporal and geographic scales. The desired outcome of this effort will involve the use of these indicators by environmental professionals for assessing progress toward protecting public health by meeting local, regional, state and national environmental health goals.

E. References
Agency for Toxic Substances and Disease Registry (ATSDR). 2001. Toxicological profile for Asbestos. Atlanta, GA: U.S. Department of Health and Human Services, Public Health Service.

Centers for Disease Control and Prevention. Third National Report on Human Exposure to Environmental Chemicals. Atlanta (GA): CDC, 2005. (Available at: http://www.cdc.gov/exposurereport).

Centers for Disease Control and Prevention. Environmental Public Health Indicators Project. Summary of Core Indicators. Atlanta, GA: CDC, 2006. (Available at: http://www.cdc.gov/nceh/indicators/summary.htm)

Commission for Environmental Cooperation. Children’s Health and the Environment in North America: A First Report on Available Indicators and Measures. 2006. (http://www.cec.org/files/PDF/POLLUTANTS/CEH-Indicators-fin_en.pdf exit EPA).

Environmental Health Project Tracking Team. America's Environmental Health Gap: Why the Country Needs a Nationwide Health Tracking Network. Baltimore, MD., 2000. (Available at: http://healthyamericans.org/reports/files/healthgap.pdf exit EPA).

Field RW, Steck DJ, Smith BJ, Brus CP, Neuberger JS, Fisher EF, Platz CE, Robinson RA, Woolson RF, Lynch CF. Residential Radon Gas Exposure and Lung Cancer: The Iowa Radon Lung Cancer Study, Am. J. Epidem. 151(11):1091-1102 (2000).

Goyer RA. Lead Toxicity: Current Concerns. Environ. Health Persp. 100(1):177-187 (1993).

Litt J, Tran N, Malecki KC, Neff R, Resnick B, Burke T. Identifying priority health conditions, environmental data, and infrastructure needs: a synopsis of the Pew Environmental Health tracking project. Environ Health Perspect. 112(14):1414-1418 (2004).

Mather FJ, White LE, Langlois EC, Shorter CF, Swalm  CM, Shaffer JG, Hartley WR. Statistical Methods for Linking Health, Exposure, and Hazards. Environ Health Perspect 112:1440-1445 (2004).

McGeehin MA, Qualters JR, Niskar AS. National Environmental Public Health Tracking Program: Bridging the Information Gap. Environ. Health Perspect. 112:1409-1413 (2004).

Nieuwenhuijsen MJ, Toledano MB, Eaton NE, Fawell J, Elliott P. Chlorination disinfection byproducts in water and their association with adverse reproductive outcomes: a review. Occup. Environ. Med. 57(2):73-85 (2000).

Thacker SB, Stroup DF, Parrish RG, Anderson HA. Surveillance in environmental public health: issues, systems, and sources. Am J Public Health. 86(5):633-638 (1996).
U.S. EPA. EPA Report on the Environment: Human Health Chapter. 2008a. (Available at: http://cfpub.epa.gov/eroe/).

U.S. EPA. Framework for Assessing the Public Health Impacts of Risk Management Decisions. 2008b. (Available at: http://www.epa.gov/hhrp/files/hhrp-framework.pdf)

U.S. EPA. Research Approaches to Assessing Public Health Impacts of Risk Management Decisions, January 22, 2008. Executive Summary. 2008c. (Available at: http://www.epa.gov/ncer/publications/workshop/humanhealth_riskmanagement_031308.pdf).

U.S. EPA. Air Quality Criteria for Ozone and Related Photochemical Oxidants (Final). U.S. Environmental Protection Agency, Washington, DC, EPA/600/R-05/004aF-cF, 2006.

U.S. EPA. Safe Drinking Water Information System (SDWIS). http://www.epa.gov/enviro/html/sdwis/.

U.S. EPA. Toxic Release Inventory (TRI). http://www.epa.gov/tri/.

Villanueva CM, Cantor KP, Cordier S, Jaakkola JJ, King WD, Lynch CF, Porru S, Kogevinas M. Disinfection byproducts and bladder cancer: a pooled analysis. Epidemiology. 15(3):357-367 (2004).

World Health Organization. Making a Difference: Indicators to Improve Children’s Environmental Health. 2003. (Available at: http://www.who.int/phe/children/en/cehindic.pdf exit EPA).

World Health Organization/Europe. Children’s Health and the Environment in Europe: A Baseline Assessment. 2007. (Available at: http://www.euro.who.int/Document/E90767.pdf exit EPA).

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).

Please note: Early career projects will not accommodate a Multiple PI application. Early career projects shall be submitted as a single Lead PI application.

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 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.

Special eligibility criteria apply to the early career portion of this RFA. Please see Section III of this RFA for details on the early career eligibility criteria.

II. AWARD INFORMATION

It is anticipated that a total of approximately $3 million will be awarded under this announcement, depending on the availability of funds and quality of applications received.  The EPA anticipates funding approximately 5 regular awards under this RFA for $500,000 or less. The EPA also anticipates funding approximately 2 early career projects for $250,000 or less (see section III for special eligibility requirements).  Requests for amounts in excess of a total of $500,000 (or $250,000 for early career projects), including direct and indirect costs, will not be considered.  The total project period requested in an application submitted for this RFA may not exceed 3 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 RFA, consistent with Agency policy, or to change the ratio of regular and early career awards, if additional funding becomes available after the original selections have been made. Any additional selections for awards will be made no later than 6 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.

The early career projects will support new, creative investigators with outstanding promise at the Assistant Professor or equivalent level. Principal investigators from applicant institutions applying for the early career portion of the RFA must meet the following additional eligibility requirements:

  1. Hold a doctoral degree in a field of science or engineering by the closing date of the RFA;
  2. Be untenured at the closing date of the RFA;
  3. By the award date, be employed in a tenure-track position (or tenure-track-equivalent position) as an assistant professor (or equivalent title) at an institution in the U.S., its territories, or possessions. Note: For a position to be considered a tenure-track-equivalent position, it must meet all of the following requirements: (1) the employing department or organization does not offer tenure; (2) the appointment is a continuing appointment; (3) the appointment has substantial educational responsibilities; and (4) the proposed project relates to the employee's career goals and job responsibilities as well as to the goals of the department/organization.

The purpose of the early career project is to fund research by the early career PI. Senior researchers may collaborate in a supporting role for early career projects. Early career applications should not propose significant resources for senior researchers and may not list senior researchers as co-PIs.

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 submitted to EPA (see Section IV.E. Submission Instructions and Other Submission Requirements for further information) 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.

In addition, to be eligible for funding consideration, a projects focus must consist of activities within the statutory terms of EPAs 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

A. Internet Address to Request Application Package
The full application must be submitted electronically via e-mail to 2009-EPHI-APPS@epa.gov (or through any authorized alternate submission methods described below). All necessary forms are available at http://www.epa.gov/ncer/rfa/forms.

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 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 available at http://www.epa.gov/ncer/rfa/forms. The form includes an Additional Key Contacts page to be completed for additional investigators. 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 Principal Investigator. 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 and References
    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 (5 pages)
      Existing data is defined as information previously collected for other purposes or from other sources, available to the applicant at the time of the application, through questionnaires and other survey instruments; physical, chemical, biological and anatomical measurements; automated electronic and other surveillance; and other methods. Secondary data is data that is derived from the analysis, combination, or derivation of one or more sources of existing data.

      Projects supported from this solicitation will involve the processing of information and data, development and testing of models, and/or the development of environmental technology (whether hardware-based or via new techniques). Applicants must provide a Quality Assurance Statement (QAS) regarding the processes that will be used to ensure that the existing data and other information used in the project(s) proposed will 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 five (5) 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 with regard to the use of existing and/or secondary data:
        1. Identify the types of existing and/or 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 existing and/or secondary data and discuss the rationale for its selection.
        3. Describe the procedures for determining the quality of the existing and/or secondary data.
        4. Specify quality requirements for the use of the secondary data sources for this application. Accuracy, precision, representativeness, completeness, and comparability need to be addressed, if applicable.
        5. Describe how the researchers will account for any possible differences in the protocols or methods used to collect the existing and/or secondary data, so that inferences drawn from the data are credible and reasonable. This should include a description of how researchers will handle data that does not meet the data quality requirements.
        6. Describe the plan for managing the data and ensuring its integrity.
        7. Establish a plan to identify the sources of the existing and/or secondary data in all deliverables/products.
      4. Describe the scope and purpose of any models that will be developed, tested and/or utilized in the research project, key assumptions to be made during development/refinement, requirements for code development, and how the(se) model(s) will be documented.
        1. Discuss the role and appropriateness of the model in meeting the specific objective(s) of the study.
        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:
        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. 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 secondary data resulting from an agreement under this RFA available in a format and with documentation/metadata such that they may be used by others in the scientific community. This includes data derived from the analysis of other existing data and/or model development conducted 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)
  6. Budget and Budget Justification
    1. Budget
      Prepare a master budget table using SF-424A Budget Information for Non-Construction Programs (aka SF-424A), available at http://www.epa.gov/ncer/rfa/forms/. Only complete Section B-Budget Categories. Provide the object class budget category (a. - k.) amounts for each budget year under the Grant Program, Function or Activity heading. Each column reflects a separate budget year. For example, Column (1) reflects budget year 1. The total budget will be automatically tabulated in column (5).

      If a subaward, such as a subagreement with an educational institution is included in the application, provide a separate SF-424A and budget justification for the subaward. Include the total amount for the subaward under Other in the master SF-424A. 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. Applicants must not submit letters of support from EPA staff.

    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 either the regular award or the early career award. It is the responsibility of the applicant to identify the proper FON. Failure to do so could result in an inappropriate peer review assignment. Each application must be submitted using a single FON.

      The Funding Opportunity Numbers for this RFA are:

      Exploring Linkages between Health Outcomes and Environmental Hazards, Exposures, and Interventions for Public Health Tracking and Risk Management, EPA-G2009-STAR-B1

      Early Career Projects: Exploring Linkages between Health Outcomes and Environmental Hazards, Exposures, and Interventions for Public Health Tracking and Risk Management, EPA-G2009-STAR-B2

    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 submitted no later than 4:00 pm Eastern Time on the solicitation closing date. Applications submitted 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/).

Solicitation Closing Date: Wednesday, August 5, 2009, 4:00 pm Eastern Time (applications must be submitted to EPA 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:

  1. 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.
  2. 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.

If you do not have the technical capability to utilize the electronic mail 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 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 submitted by the solicitation closing date and time identified above.

The applicant must submit the full application package, as described in Section IV.B, in PDF format via electronic mail to 2009-EPHI-APPS@epa.gov with the funding opportunity number (FON) in the subject line.

  1. Preparing for Submission. All required forms can be found at: (http://www.epa.gov/ncer/rfa/forms).
    Note: The electronic submission of your application package must be made by an official representative of your organization who is authorized to sign for Federal assistance. Submission instructions are updated on an as-needed basis. Please provide your authorized representative with a copy of the following instructions to avoid submission delays that may occur from the use of outdated instructions.
  2. Acknowledgement of Receipt. The complete application must be submitted to
    2009-EPHI-APPS@epa.gov no later than 4:00 pm Eastern Time on the solicitation closing date (see Submission Dates and Times). 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 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. Application for Federal Assistance (SF 424): Complete the form except for the competition ID field.
    2. EPA Key Contacts Form 5700-54: Complete the form. If additional pages are needed, see (c) below.
    3. 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, 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.).
  4. Submitting the application. The full application package must be e-mailed to
    2009-EPHI-APPS@epa.gov by an authorized representative of your organization.  Note: Minor problems are uncommon, but may still occur, with electronic mailing of files.
  5. E-mail Transmission Difficulties.

    Please note that if you choose to submit your materials via email, you are accepting all risks attendant to email submission including server delays and transmission difficulties. Email submissions exceeding 15MB will experience delays. For these size submissions, applicants should submit their application materials via hardcopy. Submissions above 70 MB will not be received by the Agency and should be submitted in hardcopy.

    Please do not send compressed files, particularly those with a .zip file extension. The Agencys e-mail server will delete these kinds of file attachments. If necessary, you may choose to divide your application into smaller pieces and e-mail smaller file attachments separately.

    If transmission difficulties that result in a late transmission, no transmission, or rejection of the transmitted application are experienced, send an email to Ron Josephson (Josephson.Ron@epa.gov) with the FON in the subject line within one day after the closing date.  The email should detail the transmission problems experienced and include any error messages.  The email should also include information demonstrating that you attempted to submit the application package by the due date in Section IV of the RFA.

    The Agency may decide to review the application if it is clearly demonstrated that transmission difficulties were due solely as a result of problems associated with EPA servers and documentation that these instructions were followed is provided. The decision regarding acceptance of the application for review will be made by the Agency and provided to the applicant within ten calendar days of the request.

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 peer review score.

Individual external peer reviewers consider an applications merit based on the criteria below. Criteria 1-5 are listed in descending order of importance:

  1. Research Proposal (criteria 1a through 1f are essentially equal):
    1. The originality and creativity of the proposed research, the appropriateness and adequacy of the proposed research methods, and the Quality Assurance Statement.
    2. 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. 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.
  4. 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.
  5. 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 managing and completing each agreement, and (ii) history of meeting the reporting requirements under those agreements.

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 managed and completed; if not successfully managed and completed, 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 managing and completing 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 toward 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 Peer Review Results document summarizing the scientific review 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 (10 pp, 42 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 made possible by EPA grant number _______. Its contents are solely the responsibility of the grantee and do not necessarily represent the official views of the EPA. Further, the EPA does not endorse the purchase of any commercial products or services mentioned in the 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 exit EPA.

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: Maggie Breville (breville.maggie@epa.gov); phone: 703-347-8050

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