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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

Early Indicators of Environmentally Induced Disease

This is the initial announcement of this funding opportunity.

Sorting Code Number: 2005-STAR-C1
Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: October 29, 2004
Solicitation Closing Date: February 23, 2005
Application receipt deadline date: February 23, 2005, 4:00 p.m. E.S.T.

Technical Contacts:
Kacee Deener; Phone: 703-347-8514; email: deener.kathleen@epa.gov
Nigel Fields; Phone: 202-564-3405; email: fields.nigel@epa.gov

Eligibility Contact:
Thomas Barnwell; Phone: 202-343-9862; email: barnwell.thomas@epa.gov

Table of Contents:
SUMMARY OF PROGRAM REQUIREMENTS
  Synopsis of Program
  Award Information
  Eligibility Information
  Application Materials
  Contact Person(s)
FUNDING OPPORTUNITY DESCRIPTION
  Introduction
  Background
  Specific Areas of Interest
  References
  Special Requirements
  Authority and Regulation
AWARD INFORMATION
ELIGIBILITY
  Eligible Applicants
  Cost Sharing
APPLICATION AND SUBMISSION INFORMATION
  Address to Request Application Package
  Content and Form of Application Submission
  Sorting Code
  Submission Dates and Times
  Intergovernmental Review
  Funding Restrictions
  Other Submission Requirements
APPLICATION REVIEW INFORMATION
  Criteria
  Review and Selection Process
  Anticipated Announcement and Award Dates
AWARD ADMINISTRATION INFORMATION
  Award Notices
  Administrative and National Policy Requirements
  Reporting
AGENCY CONTACTS

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

SUMMARY OF PROGRAM REQUIREMENTS

Synopsis of Program:

The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications proposing early indicators of environmentally induced disease. EPA is specifically interested in research that will develop methods and tools that can be used as indicators or predictors of environmentally induced effect or disease. These methods and tools should be useful in longitudinal molecular epidemiology studies such as the National Children’s Study (NCS) (http://www.nationalchildrensstudy.gov)exit EPA. The following are of interest:

  • Development of diagnostic matrices or tools for assessing overall risk of developing environmentally induced disease. It is expected that biological markers would be one component of the matrix or tool, and that other information such as questionnaire data, ambient measures, social factors, and other variables as applicable would be combined and analyzed in a way that can provide an overall picture or estimation of the likelihood or risk of developing disease.
  • Development of a series of biomarkers that indicate the likelihood of developing environmentally induced disease.

Health endpoints of interest to EPA are:

  • Pregnancy outcomes
  • Neurodevelopment and behavior
  • Asthma
  • Physical development and obesity
  • Environmentally induced chronic diseases such as cancer

Responsive proposals must focus on an environmentally induced disease that is associated with a chemical exposure. However, it may be appropriate to consider other exposures in addition to the chemical exposure. Priority health endpoints and exposures are described in greater detail in the RFA.

This is the initial announcement for this year’s program. Although not anticipated, should modifications of this announcement be necessary, they will be posted.

Award Information:
Anticipated Type of Award: Grant
Estimated Number of Awards: Approximately 4-6 awards
Anticipated Funding Amount: Approximately $3 million total costs
Potential Funding per Grant: Up to $250,000/year with a duration of 2 or 3 years and no more than a total of $750,000, including direct and indirect costs. Cost-sharing is not required. Proposals with budgets exceeding the total award limits will not be considered.

Eligibility Information:
Institutions of higher education and not-for-profit institutions located in the U.S., and Tribal, state and local governments, are eligible to apply. See full announcement for more details.

Application Materials:
The necessary forms for submitting a STAR application will be found on the NCER web site, http://www.epa.gov/ncer/rfa/forms/.

Contact Person:
Technical Contact:
Kacee Deener; Phone: 703-347-8514; email: deener.kathleen@epa.gov
Nigel Fields; Phone: 202-564-3405; email: fields.nigel@epa.gov

Eligibility Contact:
Thomas Barnwell; Phone: 202-343-9862; email: barnwell.thomas@epa.gov

FUNDING OPPORTUNITY DESCRIPTION

Introduction

EPA’s Office of Research and Development (ORD) conducts research that contributes to the scientific foundation for risk assessment and risk management decisions. One of the high-priority research areas identified by ORD is the development of tools and techniques that can be used to improve health risk assessment, including tools that can be used as early indicators of disease. EPA currently supports a number of research grants resulting from previous solicitations that focus on the development of novel tools and techniques to improve risk assessment. Information regarding current research can be found on ORD’s National Center for Environmental Research (NCER) homepage at http://www.epa.gov/ncer.

Background

In 1997, the Presidential Task Force on Environmental Health Risks and Safety Risks to Children was charged with developing strategies to reduce the risk of environmental exposures to children. The Task Force, co-chaired by the Secretary of Health and Human Services and the Administrator of the EPA, and comprised of seven additional Cabinet-level members, recommended a longitudinal cohort study of the environmental impacts on children to identify and quantify these risks. In October 2000, the Children’s Health Act of 2000 was signed into law. This Act authorized the development of the National Children’s Study (NCS), a longitudinal study of the effects of environmental pollutants on children’s health and development. The mission of the NCS is to examine the effects of environmental influences on the health and development of more than 100,000 children across the United States, following them from before birth until age 21.

At the same time, EPA has become increasingly aware of the genetic, biological, environmental, as well as psychosocial susceptibilities of children. These susceptibilities affect children’s exposures to environmental toxicants and, in some cases, adversely affect their development and/or health acutely and/or chronically. Additionally, preconception, in utero or childhood exposures could impact health later in life - either as an older child or as an adult. Since 1996, NCER has funded a variety of research projects investigating environmental disease etiology, intervention methodologies, gene-environment interactions and genetic variations— all targeted at deepening the overall scientific understanding of what it means to be differentially susceptible to exposure or disease. Additionally, NCER has issued several Requests for Applications (RFAs) on the subject of biomarkers in an effort to develop new tools that can help refine estimates of exposure and dose, predict susceptibility, and provide valid markers of disease. With this RFA, there is an opportunity to apply research to the development of a major epidemiological research project investigating and defining the relationship of environmental exposures with the health and development of children. The research developed in response to this RFA can provide important contributions to the broader scientific and medical communities, and also provide innovative and advanced methods and tools that can be used in longitudinal molecular epidemiology studies by providing valid, robust, and predictive measures or markers of environmentally related disease.

Biomarkers

Biological markers or biomarkers are observable properties of an organism that indicate variation in cellular or biochemical components, structure or function and that can be measured in biologic systems or samples (Bearer, 1998). Biomarkers can be used to estimate prior exposure, to identify changes and effects occurring within an organism, and to assess underlying susceptibility of an organism. They are useful for understanding the nature and extent of human exposure and risk of disease or adverse outcome from exposure to environmental toxicants (Travis, 1993). They can serve as quantitative measures of chemical exposures and biologically effective doses, as well as early warning signals of biologic effect. They can help increase the understanding of the processes by which: (1) a chemical is transported and transformed within an organism to produce a dose to a target tissue, and (2) the interactions at the cellular and molecular levels can lead to a toxic endpoint. In other words, biomarkers may measure precursor molecular or cellular events that precede the onset of an adverse outcome or disease. Additionally, biomarkers of susceptibility are measures of biological differences or genetic polymorphisms that may cause some individuals to be more susceptible to environmentally induced diseases.

It is useful to envision the processes that link exposure, dose, and effect as a continuum, as shown in figure 1.

Figure 1 (Adapted from DeCaprio, 1997)

Events and parameters along the continuum, such as exposure, internal dose, biologically effective dose, early biological effect, altered structure and/or function, and clinical disease, can potentially be observed and quantified using biomarkers. Markers of internal dose are direct measures of a chemical or its active metabolites in cells, tissues or body fluids. These markers may integrate multiple portals of entry and fluctuating exposures, and relate time of exposure to internal dose (Strickland, 2002). Markers of biologically effective dose assess the interaction of toxicants with their molecular targets, and markers of early biological effect assess the molecular sequelae of toxicant-cell interactions (Strickland, 2002). Markers of altered structure and/or function are useful for assessing morphological and/or functional changes following toxicant-cell interactions.

Since 1998, EPA, through the STAR grants program, has funded work on the subject of biomarkers. Much of this work has been focused on the development of novel, non-invasive markers of exposure and/or dose. Some examples include the development of saliva assays to assess pesticide exposure, and the measurement of pesticide metabolites in urine as markers of pesticide exposure. Some work has also focused on the development of susceptibility markers, such as genetic polymorphisms of detoxification enzymes. To date, there has not been much research on biomarkers of early effect or precursor events.

Recent data from epidemiological studies examining the associations of chemical exposures on children’s health have indicated that exposure-effect relationships are certainly not simple, and may be affected by many other stressors. Early life exposures, such as in utero exposures, may impact health outcomes later in life, complicating the examination of the post-natal exposure relationship to health effects. Psychosocial factors may also impact health status. Nutritional status, socioeconomic status, and many other factors can impact and interact with many of the same health endpoints of concern in environmental epidemiology studies.

New Tools for Health Risk Prediction

A major goal of public health is to prevent or mitigate the disease process. In order for this to happen, clinicians must have some sort of indication that a person is at risk of developing the disease. For environmentally mediated disease, exposure information is certainly one of the first steps, and valid exposure measures are extremely important. The linkage of these exposure measures to dose and to early biological response not only provides important scientific information about toxicant mechanism of action, but when taken together, may be able to provide an overall picture of disease risk. Effect biomarkers are important for several reasons. A biomarker of effect has been defined as “any qualitative or quantitative alteration that is predictive of a health impairment” (Bearer, 1998). These can be anything from alterations in tissues or organs, early events in the biological process that predict development of disease, or a response that is peripheral to a disease process, but that nonetheless, is correlated with it and, therefore, can be used to predict development of the disease (Bearer, 1998).

Effect biomarkers can be used to substitute for classical endpoints in epidemiology studies. For example, an early biological event can be used as a predictor if it is known that the event is highly correlated with developing clinical disease. Ideally, biomarkers are on the direct pathway from the initiation to the occurrence of clinical disease.

Figure 2 (Adapted from Bonassi, 2001)

A biomarker can be extremely important for identifying and/or quantifying exposure, dose, early biological changes or early health effects. Using a suite of biomarkers (exposure, susceptibility, and effect) could provide a manner in which to predict the risk of developing environmentally related disease. It can also provide researchers with an exciting new tool to use in epidemiological studies, and it can provide clinicians with the opportunity for implementation of prevention and intervention strategies. For example, exposure biomarkers can provide information about exposure and/or dose but they provide little information about resulting health endpoints. Having information on exposure combined with information about genetic susceptibility, however, begins to provide a connection between environmental exposure and disease risk. Further, information about an early biological effect can provide a clearer picture of one’s risk of developing disease. The addition of information on factors that may affect the association of exposures to environmental toxicants and health effects (such as nutritional status and socioeconomic information) can provide an overall indication of disease risk.

Validation of Indicators

It is important that biomarkers be evaluated for effectiveness in quantifying the event or condition of interest. To evaluate the use of a biologic measurement as a biomarker, one must understand the relationship between the marker and the condition/disease of interest. Sensitivity and specificity are both critical components of the evaluation process. Sensitivity refers to the ability of a measurement to detect positive responses, whereas specificity refers to the ability of a measurement to identify negative responses (in order to limit the number of false positives). Since one of the primary purposes of biomarkers in environmental health research is to identify exposed groups in order to predict or prevent disease, the biomarkers must not only be evaluated for their ability to assess the presence or absence of an exposure or disease, but also for their ability to quantify the exposure, dose, or level of disease (Bearer, 1998).
The evaluation of biomarkers includes the “backward” process of associating a marker with an exposure, and the “forward” process of linking a biomarker with an effect. The evaluation of a biomarker depends on its anticipated use. A biomarker of exposure observed before onset of disease may have a low predictive value, but may allow long-term monitoring of an exposed population. On the other hand, a biomarker of effect that is expressed long after the exposure could be of relatively little use in exposure assessment, but may be very useful in predicting progression of disease or in assessing risk. Animal models are useful in understanding the mechanistic basis of the expression of markers and the relationship between exposure, early effects, mode of action, and disease. The validity of a biomarker of effect depends on the reliability of studies that provide the background data, particularly on mechanisms. Estimates of the sensitivity of a biomarker should include its evaluation in an unexposed population or unexposed animals to determine a baseline value for the marker (Bearer, 1998).

Specific Research Areas of Interest

EPA, through the STAR program, is interested in supporting research that will develop methods and tools that can be used as indicators or predictors of environmentally induced effect or disease. These methods and tools should be useful in a longitudinal molecular epidemiology study such as the National Children’s Study (http://www.nationalchildrensstudy.gov)exit EPA. The following are of interest:

  • Development of diagnostic matrices or tools that are useful for assessing overall risk of developing environmentally induced disease. It is expected that biological markers would be one component of the matrix or tool, and that other information such as questionnaire data, ambient measures, social factors, and other variables as applicable would be combined and analyzed in a way that can provide an overall picture or estimation of the likelihood or risk of developing disease.
  • Development of a series of biomarkers that indicate the likelihood of developing environmentally induced disease.

Health endpoints of interest to EPA are:

  • Pregnancy outcomes: Many pregnancy outcomes, including preterm delivery and birth defects, are plausibly related to environmental conditions and are understudied. These early life events can have a profound impact on child health and development throughout life.
  • Neurodevelopment and behavior: Assessment of child neurodevelopment and behavior can be important in environmental epidemiology studies. Multiple environmental factors are potentially associated with severe health concerns such as autism and schizophrenia, as well as more commonly occurring childhood disorders such as depression and learning disabilities.
  • Asthma: While there is a substantial body of research into environmental factors that can trigger asthma attacks or exacerbate existing asthma, there is a need for research on the contributions the environment and gene-environment interactions have on the development of asthma.
  • Physical development and obesity: Environmental exposures early in life may be associated with disorders of physical development (such as altered puberty). Additionally, obesity, as a pre-existing condition, may contribute to one’s susceptibility to environmental contaminants. The longitudinal nature of many epidemiology studies enable researchers to examine the interaction of multiple environmental factors with an individual’s genetic composition to provide insight not only into growth-related disorders, but also to provide data on variations in growth, and physical and reproductive development that may be affected by the environment.
  • Environmentally induced chronic diseases such as cancer: Because of the low cancer incidence in children and the long latency period for most cancers, development of pre-disease indicators is important for effective investigation of disease etiology. Early effect biomarkers, such as protein and/or DNA adducts, may be combined with exposure, dose, and susceptibility information to more effectively predict risk of developing disease and may also be useful for more effectively investigating disease etiology.

Responsive proposals must focus on an environmentally induced disease that is associated with a chemical exposure. However, in addition to the chemical exposure, it may be appropriate to consider other exposures, including:

  • Physical environment. Aspects of the physical environment, including housing quality and neighborhood and community conditions, may relate to child health and development. In addition, the influence of physical factors such as radiation (electromagnetic, ultrasound, microwave, x-irradiation), light, and noise may be considered.
  • Chemical exposures. Exposure to chemical environmental contaminants generally occurs through human contact with air, water, soil, dust, food or industrial products. Pollutant exposures of interest include metals, PCBs and dioxins, phthalates, organic and inorganic pesticides and herbicides. Exposure to many of these compounds and their mixtures is ubiquitous at low background levels. Select specific populations with unique exposure scenarios may also be considered.
  • Biologic environment. The biologic environment includes exogenous factors (e.g., infectious agents, endotoxins, diet) and individual responses to those factors (e.g., inflammatory response, glucose metabolism). In utero and early life exposures have potential implications for a wide range of health conditions including birth outcomes, developmental outcomes, asthma, obesity, and cardiovascular disease. Understanding those associations as well as physiologic mechanisms underlying those relationships, including the influence of genetic composition on those interactions, is important.
  • Genetics. Longitudinal environmental epidemiological studies offer a unique opportunity to investigate the genetic component of many health outcomes. Although it is recognized that genetic factors play a role in many conditions, the mechanism behind the genetic contribution to specific diseases, such as autism, remains unknown. In addition, the quantitative contribution of genetics to more general conditions is also unknown. A complete understanding of the effects of environmental factors requires elucidation of the interactions between these factors and genes, including the roles played by various polymorphisms in environmentally responsive genes and the effects of exposures on gene expression. Large sample sizes allow for examination of the interaction between genetic make-up and chemical, biologic, and social exposures on many outcomes. The longitudinal and prospective nature of large environmental epidemiology studies offers the possibility of examining the potential development of somatic mutations in relation to specific exposures.
  • Psychosocial milieu. Some aspects of the psychosocial environment have the potential to influence a child's health, either directly or indirectly, by affecting exposure to the chemical or physical environment. Examples include: families and households, socioeconomic status, social networks and social support, neighborhoods and communities, formal institutions, and public policy. In addition to the putative influence on the health of an individual, social environmental factors may be an important area of consideration for investigation of health disparities.

Special notes about relevant proposals:

  • Validation of markers of exposure, effect or disease is essential. A plan for validation of all biomarkers used must be a part of the grant application. Although validated markers may be used as part of a suite of markers or a larger diagnostic tool, evidence of validation must be provided. Additionally, a plan to determine the tool’s ability to predict disease must be included in the proposal. A plan for determining the sensitivity and specificity of the markers must also be included. Estimates of the sensitivity of a biomarker must include its evaluation in an unexposed population or unexposed animals to determine a baseline value for the marker(s).
  • Small pilot studies in human populations are encouraged to demonstrate applicability to a large multi-center longitudinal study in humans. Development of the biomarkers in an animal model is acceptable but validation in humans is required so it is clear that the marker(s) can be incorporated into longitudinal epidemiology studies.
  • The results of the research, if successful, should lead to realistic, practical, and appropriate methods or measures that can be used in longitudinal epidemiology studies and that will more broadly benefit the scientific community as a whole.
  • Research should be applicable to exposures and outcomes described in this RFA. Additionally, priority will be given to methods and tools applicable in humans after gestation and infancy until puberty.
  • Use of advances in “omic” technologies to develop markers or tools is encouraged.

REFERENCES

  1. Bearer, C.F. (1998). Biomarkers in Pediatric Environmental Health: A Cross-Cutting Issue. Environmental Health Perspectives 103 (Supplement 3): 813-816.
  2. Bonassi, Stefano and Au, William W. (2001). Biomarkers in molecular epidemiology studies for health risk populations. Mutation Research, 511 (200): 73-86.
  3. DeCaprio, Anthony P. (1997). Biomarkers: Coming of Age for Environmental Health and Risk Assessment. Environmental Science and Technology, 31(7); 1837-1847.
  4. Strickland, Paul. (2002). Introduction to Molecular Epidemiology and Biomarkers. Johns Hopkins Bloomberg School of Public Health (from course materials), Baltimore, MD.
  5. Travis, C.C. (Ed.). (1993). Use of Biomarkers in Assessing Health and Environmental Impacts of Chemical Pollutants. New York, NY: Plenum Press.

Special Requirements

Post-award collaboration with scientists involved in conducting longitudinal epidemiology studies (such as the National Children’s Study) will be encouraged. Additionally, it is possible that research funded through this RFA may be funded as a cooperative agreement rather than a grant.

Authority and Regulations

The authority for this RFA and resulting awards is contained in the Toxic Substances Control Act, Section 10, as amended 15 U.S.C. 2609; and the Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, as amended 7 U.S.C. 136r; and the Clean Air Act, Section 103, as amended, Public Law 95-95, 42 U.S.C. 7401 et seq. and the Clean Water Act, Section 104, as amended, Public Law 95-217, 33 U.S.C. 1251 et seq.

AWARD INFORMATION

It is anticipated that a total of approximately $3 million will be awarded, depending on the availability of funds. EPA anticipates funding approximately 4-6 grants under this RFA. The projected award per grant is $125,000 to $250,000 per year total costs, for up to 3 years. Requests for amounts in excess of a total of $750,000, including direct and indirect costs, will not be considered. The total project period for an application submitted in response to this RFA may not exceed 3 years. Funding in subsequent years will be contingent upon satisfactory progress.

ELIGIBILITY

Eligible Applicants

Institutions of higher education and not-for-profit institutions located in the U.S., and Tribal, state and local governments, are eligible to apply. Universities and educational institutions must be subject to OMB Circular A-21. Profit-making firms are not eligible to receive grants from EPA under this program.

Eligible nonprofit organizations include any organizations that meet the definition of nonprofit in OMB Circular A-122. However, nonprofit organizations described in Section 501(c)(4) of the Internal Revenue Code that engage in lobbying activities as defined in Section 3 of the Lobbying Disclosure Act of 1995 are not eligible to apply.

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

Federal agencies may not apply. Federal employees are not eligible to serve in a principal leadership role on a grant, and may not receive salaries or in other ways augment their agency's appropriations through grants made by this program. Nonetheless, federal employees may interact with grantees so long as their involvement is not essential to achieving the basic goals of the grant. EPA encourages interaction between its own laboratory scientists and grant principal investigators 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.

The principal investigator’s institution may enter into an agreement with a federal agency to purchase or utilize unique supplies or services unavailable in the private sector. Examples are purchase of satellite data, census data tapes, chemical reference standards, analyses, or use of instrumentation or other facilities not available elsewhere. A written justification for federal involvement must be included in the application, along with an assurance from the federal agency involved which commits it to supply the specified service.

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

Cost Sharing

Institutional cost-sharing is not required and, therefore, does not have to be included in the budget table. However, if the applicant intends to cost-share, a brief statement concerning cost-sharing should be added to the budget justification, and estimated dollar amounts must be included in the appropriate categories in the budget table.

APPLICATION AND SUBMISSION INFORMATION

Address to Request Application Package

Application forms and instructions for applying can be found on the EPA NCER web site at:
http://www.epa.gov/ncer/rfa/forms/.

Content and Form of Application Submission

The initial application is made through submission of the materials described below. It is essential that the application contain all information requested and be submitted in the formats described. Noncompliance with formatting instructions (page limits, font size, etc.) is grounds for administrative dismissal. Please note that if an application is being considered for an award (i.e., after external peer review and internal review), additional forms and other information will be requested by the EPA Project Officer. The application must contain the following:

A. Standard Form 424: The applicant must complete SF424. This form will be the first page of the application. Instructions for completion of the SF424 are included with the form. The form must contain the original signature of an authorized representative of the applying institution. Please note that both the Principal Investigator and an administrative contact are to be identified in Section 5 of the SF424.

Regarding Block 16 of the SF 424 -- Research funded under this program may be eligible under E.O. 12372, “Intergovernmental Review of Federal Programs,” if it affects public health or if an environmental impact statement is required. If applicable, an applicant should consult the office or official designated as the single point of contact in his or her state for more information on the process the state requires in applying for assistance, if the state has selected the program for review.

B. Key Contacts: The applicant must complete the Key Contacts Form (NCER Form 1) as the second page of the application. The Key Contacts Form and a continuation page are available at http://www.epa.gov/ncer/rfa/forms. A copy of this form should also be completed for major sub-agreements (contacts at the institutions of primary co-investigators). Please make certain that all contact information is accurate. An e-mail will be sent by EPA NCER (from receipt.application@epa.gov; e-mails to this address are not accepted) to the Principal Investigator (with a copy to the Administrative Contact) to acknowledge receipt of the application and to transmit other important information. If an e-mail acknowledgment has not been received within 30 days of the submission deadline, then immediately contact the project officer listed under "Contacts" in this solicitation. Please note: Due to often lengthy delays in delivery, it is especially important that you monitor EPA NCER confirmation of receipt of your application when using regular mail.

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

D. Abstract: The abstract is a very important document. All abstracts are provided to the peer review panelists and some of the panelists may read only the abstract. Abstracts also play a critical role in programmatic review (see “Application Review Information”). Therefore, it is critical that the abstract accurately describe the research being proposed and convey all the essential elements of the research. Also, the abstracts of applications that receive funding will be posted on the EPA NCER web site.

The abstract, limited to one page, should include the information indicated in the example format (http://www.epa.gov/ncer/rfa/forms) and described below (1-8). Examples of abstracts for current grants may be found on the NCER web site.

1. Research Category and Sorting Code: Enter the full name of the solicitation under which your application is submitted and the code that corresponds to the appropriate RFA topic.
2. Title: Use the exact title of your project as it appears in the application. The title must be brief, yet represent the major thrust of the project. Because the title will be used by those not familiar with the project, strike a balance between highly technical words and phrases and more commonly understood terminology. Do not use phrases such as “research on.”
3. Investigators: List the Principal Investigator, then the names and affiliations of each co-investigator who will significantly contribute to the project. Provide a web site URL or an E-Mail contact address for additional information.
4. Institution: In the same order as the list of investigators, list the name and city/state of each participating university or other applicant institution. The institution applying for assistance must be clearly identified.
5. Project Period: Show the proposed project beginning and ending dates.
6. Project Cost: Show the total dollar request, including direct and indirect costs, to the EPA for all grant years (the entire project period).
7. Project Summary: Provide three subsections addressing: (a) the objectives of the study (including any hypotheses that will be tested), (b) the experimental approach to be used (a description of the project proposed), and (c) the expected results of the project and how it addresses the research needs identified in the solicitation, including the estimated improvement in risk assessment or risk management that will result from successful completion of the proposed work.
8. Supplemental Keywords: Supply keywords to assist database searchers in finding your research, without duplicating terms already used in the text of the abstract. A complete set of keywords is very important. A list of suggested keywords will be found at http://www.epa.gov/ncer/rfa/forms.

E. Research Plan and Quality Assurance Statement

Research Plan:

Applications should be focused on a limited number of research objectives that can be adequately and clearly demonstrated to meet the RFA requirements. Explicitly state the main 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 the reviewers can evaluate the appropriateness of your approach and the tools you intend to use. The statement: “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. 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. This section should also include any background or introductory information that would help explain the objectives of the study. If this application is for continuation of research supported by an existing or former grant awarded under the STAR program, indicate the number of the grant and provide a brief report of progress and results achieved under that grant (one to two pages recommended).
  2. Approach: Outline the research design, methods, and techniques that you intend to use in meeting the objectives stated above (five to 10 pages recommended).
  3. Expected Results or Benefits: Describe the results you expect to achieve during the project and the benefits of the results. This section should also discuss how the research results will lead to solutions to environmental problems and improve the public’s ability to protect the environment and human health. A clear, concise description will help NCER understand the merits of the research (one to two pages recommended).
  4. General Project Information: Discuss other information relevant to the potential success of the project. This should include facilities, personnel, project schedules, proposed management, interactions with other institutions, etc. Applications for multi-investigator projects must identify project management and the functions of each investigator within a team and describe plans for communication and sharing of data (one to two pages recommended).
  5. Important Attachments:

References cited are in addition to the 15-page Research Plan limit.

Letters of intention that are limited to one brief paragraph merely assuring commitment of a resource (e.g., use of a person’s time or equipment) not under the control of the applicant institution may be included and are in addition to the 15 pages.

Letters of intention that exceed one brief paragraph will be considered a part of the appendix.

Appendices may be included but must remain within the 15-page limit.

Quality Assurance Statement (two pages in addition to the 15-page research plan):

For any project involving data collection or processing, conducting surveys, environmental measurements, modeling or the development of environmental technology (whether hardware-based or via new techniques) for pollution control, provide a Statement on processes that will be used to assure that results of the research satisfy the intended project objectives. EPA is particularly interested in the quality controls for data generation and acquisition, and how data validation and usability will be verified. The Statement must describe a system that complies with ANSI/ASQC E4, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs, and must not exceed two consecutively numbered, 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins.

For each item below, either present the required information, reference the specific location of the information in the Research Plan, or provide a justification of why the item does not apply to the proposed research.

  1. Identify the individual who will be responsible for the quality assurance and quality control aspects of the research. [Quality assurance (QA) is an integrated system of management activities involving planning, implementation, documentation, assessment, and improvement to ensure that a process or item is of the type and quality needed for the project. Quality control (QC) is the system of technical activities that measures the attributes and performance of a process or item against defined standards, to verify that they meet the stated requirements.]
  2. Discuss the activities to be performed or the hypothesis to be tested and criteria for determining acceptable data quality. (Note: Such criteria may be expressed in terms of precision, accuracy, representativeness, completeness, and comparability or in terms of data quality objectives or acceptance and evaluation criteria.) Also, these criteria must be applied to determine the acceptability of existing, or “secondary,” data to be used in the project. (In this context, secondary data may be defined as data previously collected for other purposes or from other sources.)
  3. Describe the study design. Include sample type(s) and location requirements, all statistical analyses that were or will be used to estimate the types and numbers of physical samples required, or equivalent information for studies using survey and interview techniques, or describe how new technology will be benchmarked to improve existing processes, such as those used by industry.
  4. Describe the procedures that will be used in the calibration and performance evaluation of all analytical instrumentation and all methods of analysis to be used during the project. Explain how the effectiveness of any new technology will be measured.
  5. Describe the procedures for the handling and custody of samples, including sample collection, identification, preservation, transportation, and storage, or how the accuracy of test measurements will be verified.
  6. Discuss the procedures for data reduction and reporting, including a description of all statistical methods to make inferences and conclusions, with identification of any statistical software to be used; discuss any computer models to be designed or utilized and describe the associated verification and validation techniques.
  7. Describe the quantitative and/or qualitative procedures that will be used to evaluate the success of the project, including any plans for peer or other reviews of the study design or analytical methods prior to data collection.

ANSI/ASQC E4, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs, is available for purchase from the American Society for Quality, phone 1-800-248-1946, item T55. Only in exceptional circumstances should it be necessary to consult this document. An EPA guidance document, Guidance on Satisfying EPA Quality System Requirements for STAR Grants (EPA QA/G-1STAR) is available for potential applicants and addresses in detail how to comply with ANSI/ASQC E4 for STAR grants. This may be found on the Internet at http://www.epa.gov/ncer under “Guidance and FAQs.”

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

Page allowances for the following sections are in addition to those allowed for the Research Plan and Quality Assurance Statement.

F. Budget and Budget Justification:

Budget:

Prepare a budget table using the guidance and format found at http://www.epa.gov/ncer/rfa/forms/, select “All required forms.” If a sub-agreement, such as a subcontract, is included in the application, provide a separate budget for the subcontract in the same format. Include the total amount for the sub-agreement under “Contracts” in the master budget. Any project containing sub-agreements that constitute more than 40% of the total direct cost of the grant will be subject to special review. Additional justification for use of such a subcontract must be provided, discussing the need for this agreement to accomplish the objectives of the research project.

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

Budget Justification:

Describe the basis for calculating the personnel, fringe benefits, travel, equipment, supplies, contractual support, and other costs identified in the itemized budget and explain the basis for their calculation. (Special attention should be given to explaining the “travel,” “equipment,” and “other” categories.) The budget justification should not exceed 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 and locations, and other costs for each type of travel. Explain the need for any travel outside the United States. Include travel funds for annual STAR program progress reviews and a final workshop to report on results.
  4. Equipment: Identify computers, and each item to be purchased which has an estimated cost of $5,000 or more per unit and a useful life of more than one year. (Items with a unit cost of less than $5,000 are considered supplies, per regulation.)
  5. Supplies: “Supplies” means all tangible property other than “equipment.” Identify categories of supplies to be procured (e.g., laboratory supplies or office supplies).
  6. Contractual: Identify each proposed sub-agreement (grant or contract) and specify its purpose and estimated cost. Sub-agreements more than $25K should have a separate itemized budget included as part of the application.
  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.
  8. Indirect Charges: If indirect charges are included in the budget, indicate the approved rate and base with an explanation of how indirect costs were calculated.

G. Resumes and Current and Pending Support

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

Current and Pending Support: Identify any current and pending financial resources that are intended to support research related to the proposal or which would consume the time of principal investigators. Provide information on current and pending support in the format provided at http://www.epa.gov/ncer/rfa/forms for each investigator and other important co-workers.

H. Guidelines, Limitations, and Additional Requirements

Confidentiality

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

Sorting Code

At various places within the application, applicants are asked to identify the sorting code corresponding to their proposed research topic area in the solicitation. It is the responsibility of the applicant to identify the proper sorting code, based on the nature of the proposed research. Failure to do so could result in an inappropriate peer review assignment.

The sorting code must be placed at the top of the abstract (location is shown in the abstract format, http://www.epa.gov/ncer/rfa/forms), in Box 10 of Standard Form 424, and in the address on the package that is sent to the EPA (see below).

Submission Dates and Times

The original and eight (8) copies of the complete application (9 in all) and one (1) additional copy of the abstract, must be received by NCER no later than 4:00 P.M. Eastern Time on the closing date assigned to this topic area. The following is the schedule for this RFA. It should be noted that this schedule may be changed without prior notification due to factors that were not anticipated at the time of announcement. In the case of a change in the required receipt date, the new date will be posted on the NCER website.

Application Receipt Date: February 23, 2005, 4:00 p.m. E.S.T.
Earliest Anticipated Start Date: October 2005

To be considered timely, applications and initial proposals must be received by the Agency on or before the deadline date published in the RFA. Applications received after the published deadline or applications that deviate from the prescribed format will be returned to the sender without further consideration. Also, applications exceeding the funding limits described in the RFA will be returned without review.

Intergovernmental Review

Research funded under this program may be eligible under E.O. 12372, “Intergovernmental Review of Federal Programs,” if it affects public health or if an environmental impact statement is required. If applicable, an applicant should consult the office or official designated as the single point of contact in his or her state for more information on the process the state requires in applying for assistance, if the state has selected the program for review. The names and addresses of the state’s single point of contact are listed in the OMB home page at:
http://www.whitehouse.gov/omb/grants/spoc.html exit EPA

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 Public Law 95-224, the primary purpose of a grant 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 Federal Government. In issuing a grant agreement, the EPA anticipates that there will be no substantial EPA involvement in the design, implementation, or conduct of the research. If, however, the award is made in the form of a cooperative agreement, there will be substantial involvement with EPA and NCS scientists. Regardless of the type of award, the EPA will monitor research progress through annual reports provided by grantees and other contacts, including site visits, with the Principal Investigator.

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

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

Other Submission Requirements

The application and abstract must be prepared in accordance with these instructions. Informal, incomplete, or unsigned applications will be returned without review. The original, signed copy of the application must not be bound or stapled in any way. The other eight (8) required copies of the application should be secured with paper or binder clips or secure staples.

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

The following address must be used for regular mail:

U.S. Environmental Protection Agency
Peer Review Division (8725F)
Sorting Code: 2005-STAR-C1
1200 Pennsylvania Avenue, NW
Washington, D.C. 20460

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

U.S. Environmental Protection Agency
Peer Review Division (8725F)
Sorting Code: 2005-STAR-C1
1025 F Street, NW (Room 3500)
Washington, DC 20004
Phone: (202) 233-0686

APPLICATION REVIEW INFORMATION

Criteria

Consideration of an application’s merit is based on the following criteria: All else being equal, proposals that consider multiple environmental benefits will be ranked higher than those that consider only single benefits, and proposals that involve an interdisciplinary team of researchers will be ranked higher than those that include only a single discipline. These criteria are listed in descending order of importance.

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

Review and Selection Process

All grant applications are reviewed by an appropriate external technical peer review panel. In general, each peer review group is composed of non-EPA scientists, engineers, social scientists, and/or economists who are experts in their respective disciplines and are proficient in the technical subjects they are reviewing. Reviewers are asked to assign a summary score of either excellent, very good, good, fair or poor to each application. This review is designed to evaluate each proposal according to its scientific merit.

Applications that receive scores of excellent and very good from the peer reviewers are subjected to a programmatic review within the EPA to assure a balanced research portfolio for the Agency. The programmatic review considers the relevance of the proposed science to EPA research priorities, program balance, budget, and available funds. Final funding decisions are made by the NCER Director. Selected applicants will be required to provide additional information and the application will be forwarded to the grants administration office for award in accordance with the EPA’s procedures.

Anticipated Announcement and Award Dates

The following is the schedule for this RFA. Please note that this schedule may be changed without notification due to factors that were not anticipated at the time of announcement.

Application Receipt Date: February 23, 2005, 4:00 p.m. E.S.T.
Earliest Anticipated Start Date: October 2005

AWARD ADMINISTRATION INFORMATION

Award Notices

Customarily, applicants are notified about award decisions within six months of the application deadline. A summary statement of the scientific review by the peer panel will be provided to each applicant with the award or declination letter. After selection for award, applicants recommended for funding will be required to submit additional certifications and an electronic version of the revised project abstract, and may be requested to provide responses to comments or suggestions offered by the peer reviewers, a revised budget, and/or to resubmit their proposal. EPA Project Officers will contact Principal Investigators to obtain these materials. The official notification of an award will be made by the Agency’s Grants Administration Division. Before or after an award, certain applicants will be expected to provide additional quality assurance documentation.

Administrative and National Policy Requirements

Expectations and responsibilities of NCER grantees are summarized in this section. See http://www.epa.gov/ncer/guidance for full terms and conditions associated with an award, including what activities require prior approval of the EPA.

A. Meetings: Principal Investigators will be expected to budget for, and participate in, periodic All-Investigators Meetings (also known as progress reviews) approximately once per year with EPA scientists and other grantees to report on research activities and to discuss issues of mutual interest.

B. Approval of Changes after Award: Prior written approval is required from the EPA if there is to be significant change in the research that deviates markedly from work described in the application. Examples of these changes are contained in 40 C.F.R. 30.25. Prior written approval is also required from the EPA for incurring costs greater than 90 calendar days prior to award.

C. Human Subjects: A grant recipient must agree to meet all EPA requirements for studies using human subjects prior to implementing any work with these subjects. These requirements are given in 40 C.F.R. 26, referred to as the “Common Rule.” No work involving human subjects, including recruiting, may be initiated before the EPA has received a copy of the applicant’s Institutional Review Board’s (IRB) approval of the project and the EPA has also provided approval. Where human subjects are involved in the research, the recipient must provide evidence of subsequent IRB reviews, including amendments or minor changes of protocol, as part of annual reports.

D. Animal Welfare: A grant recipient must agree to comply with the Animal Welfare Act of 1966 (P.L. 89-554), as amended. All projects involving vertebrate animals must have approval from the applying organization’s Institutional Animal Care and Use Committee before issuance of an EPA grant.

E. Data Access and Information Release: The Office of Management and Budget (OMB) Circular A-110 has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with Federal funds and (2) cited publicly and officially by a Federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. All data sets, models, and databases developed under STAR grants may become accessible to the public and therefore freely available to all researchers. If such data are requested by the public, the EPA must ask for it, and the grantee must submit it, in accordance with A-110 and EPA regulations at 40 C.F.R. 30.36.

Reporting

A grant recipient must agree to provide annual progress reports with associated summaries for posting on NCER’s web site, and a final report with an executive summary for web posting.

A 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 intends to post references to all publications resulting from the grant on the NCER web site.

EPA’s full or partial support should be acknowledged in journal articles, oral or poster presentations, news releases, interviews with reporters and other communications. Any documents developed under the agreement for distribution to the public or inclusion in a scientific, technical or other journal shall include the following statement:

This publication [article] was developed under a STAR Research Assistance Agreement No. __________ awarded by the U.S. Environmental Protection Agency. It has not been formally reviewed by the EPA. The views expressed in this document are solely those of [name of recipient] and the EPA does not endorse any products or commercial services mentioned in this publication.

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

AGENCY CONTACTS

Further information, if needed, may be obtained from the EPA official indicated below. Email inquiries are preferred.

Technical Contact: Kacee Deener; Phone: 703-347-8514; email: deener.kathleen@epa.gov
Eligibility Contact: Thomas Barnwell; Phone: 202-343-9862; email: barnwell.thomas@epa.gov

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