Grantee Research Project Results

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

CLOSED - FOR REFERENCES PURPOSES ONLY

Recipients List

Development of Environmental Health Outcome Indicators

This is the initial announcement of this funding opportunity.

Funding Opportunity Number: EPA-G2007-STAR-A1

Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: August 21, 2006
Solicitation Closing Date: December 14, 2006, 4:00 pm Eastern Time

Eligibility Contact: Tom Barnwell (barnwell.thomas@epa.gov); phone: 202-343-9862
Electronic Submissions: Bronda Harrison (harrison.bronda@epa.gov); phone: 202-564-1790
Technical Contact: Chris Saint (saint.chris@epa.gov); phone: 202-564-9839

Table of Contents:
SUMMARY OF PROGRAM REQUIREMENTS
	Synopsis of Program
	Award Information
	Eligibility Information
	Application Materials
	Contact Person(s)
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 and Instructions
Research awarded under previous solicitations

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 research that uses existing databases of environmental (ambient), biological and/or health-related data to develop indicators that reliably signal the impact of changes in environmental conditions, management approaches or policies on human health. Key to the development of such indicators is a clearer understanding of the sequence of events that link changes in the environment to human exposure and adverse health outcomes.

Award Information:
Anticipated Type of Award: Grant
Estimated Number of Awards: Approximately 6 awards
Anticipated Funding Amount: Approximately $3 million total for all awards
Potential Funding per Award: Up to a total of $500,000, including direct and indirect costs, with a maximum 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. See full announcement for more details.

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

Contact Persons:
Eligibility Contact: Tom Barnwell (barnwell.thomas@epa.gov); phone: 202-343-9862
Electronic Submissions: Bronda Harrison (harrison.bronda@epa.gov); phone: 202-564-1790
Technical Contact: Chris Saint (saint.chris@epa.gov); phone: 202-564-9839

I. FUNDING OPPORTUNITY DESCRIPTION

A. Introduction
The Office of Research and Development is committed to the identification, development and application of a new generation of outcome-based environmental health indicators¹. The use of these indicators will extend the ability of environmental scientists and managers to assess progress toward meeting established local, regional and national environmental health goals. Many traditional process indicators (e.g. decreases in air emissions, decreases in discharges to water bodies, or changes in pollutant levels in soils or sediments) already exist and are extensively used in environmental monitoring and decision-making. It is the goal of this research to investigate the feasibility of using existing data to develop indicators that signal trends in exposure and environmental human health. Useful outcome-based indicators will be created to complement traditional process-based indicators, which in tandem will more closely reflect the actual impact of environmental policy or management decisions on human health. Furthermore, these indicators may clarify the public health benefits and costs associated with further incremental changes in the environment. Key to the eventual employment of such indicators is a clearer understanding of the sequence of events that link changes in the environment to health outcomes (e.g. disease).

B. Background
Protecting the health of Americans from environmental pollutants has always been a key goal of environmental protection policies and public health programs. Environmental scientists and managers in industry and at all levels of government have taken a number of actions to fulfill this goal. These include establishing standards for pollutants in the environment, requiring limits on their release into the environment, providing procedures for permitting the use of industrial products, and educating members of the public about actions they can take to protect their health. These approaches and other regulatory and management decisions are intended to reduce people’s exposure to contaminants in the environment. Traditionally, the impact of these decisions has been evaluated using process-related indicators such as pollutant releases, permitting information or ambient chemical concentrations. Information on whether particular death and disease rates have changed, along with information on the various environmental and other factors that influence these trends, would strengthen environmental decision-making. It would also allow evaluations of the effectiveness of these decisions in protecting environmental and public health. Environmental health scientists and managers have traditionally focused on improving their ability to assess exposure, toxicity, and risk. In recent years, the emphasis has shifted to efforts aimed at elucidating the predictive linkages between pollutants and disease outcomes. A depiction of this sequence is presented in Figure 1 and is referred to as the Environmental Public Health Continuum. This has led to an increasing interest in the use of “outcome-based” indicators to quantify the status of human health and to track environmental conditions over time.

Figure 1. The Environmental Public Health Continum

For the purpose of this solicitation, environmental health outcomes are considered to be changes in human health (e.g. increased or decreased incidence of disease) that result from exposure to chemicals and/or other stresses present in the environment. An indicator is considered to be a single numerical value that can be interpolated and extrapolated to represent exposure, health outcome, and/or a health/exposure association. An indicator can be a measured quantity (e.g. concentration, dose, or toxicity) or a derived quantity (e.g. a distribution or an index) that combines information on environmental exposures, doses, or effects. In either case it is likely that statistical and/or mathematical models will be employed to represent the relationships between the various data that characterize the indicator. What differentiates an outcome-based indicator from an isolated individual measurement is an understanding of its relationship to a particular health outcome or group of health outcomes.

Outcome-based indicators focus on actual environmental or health-related results (outcomes), such as cleaner air and water, reduced exposure to pollutants, and/or reduced disease incidence rather than administrative actions (process indicators), such as the number of permits issued². At one time, process-related indicators of performance were considered sufficient indicators of progress. While process-related indicators track what actions have been taken, they do not tell us whether those actions have actually improved the environment or human health. Understanding the impact of environmental decisions on human health and measuring actual progress towards stated environmental goals requires indicators that link environmental exposures and their actual or potential effects on human health.

Exposure indicators³ measure or estimate the direct contact of humans with chemicals in their environment (see Figure 1). These indicators are quantified using ambient pollutant measurements, stochastic models of exposure (models that consider people’s activities and locations), personal monitoring data, and biological monitoring data (identifying amounts of pollutants and/or their metabolites in the body). Exposure indicators are usually related to health outcomes using information on the toxicity of a pollutant or epidemiological data that relate exposure to adverse health outcome(s).

Health outcome indicators measure the occurrence in a population of diseases or conditions that are known or believed to be caused by exposure to environmental pollutants (see Figure 1). These indicators can be used to: 1) describe the health status of a population and discover important temporal and spatial behaviors of diseases; 2) identify causal factors for specific diseases or trends which explain disease prevalence or exposure occurrence; 3) predict disease occurrences and the distribution of exposure for a specific population; or 4) evaluate the impact of environmental policy decisions or interventions.

Many studies have demonstrated an association between environmental exposure and certain diseases or health problems. Examples include radon and lung cancer⁴; lead and nervous system disorders⁵; particulate matter and cardiovascular and respiratory diseases⁶. Recent advances in the use of biological markers in human health research have improved our ability to characterize these associations with greater consistency and confidence. However, in order for these approaches to be fully effective as environmental health indicators, we need a better understanding of the links between changes in the environment, human exposure, alterations in molecular and cellular structure and function, and adverse human health outcomes. A better understanding of these relationships will provide outcome-based indicators that can be used to evaluate the effectiveness of environmental decision-making and ultimately act as surrogate measures for actual health outcomes. Furthermore, these indicators may clarify the benefits and costs associated with further incremental reductions in environmental concentrations and exposures.

The specific Strategic Goal, Objective and Sub-objective from EPA’s Strategic Plan that relate to this solicitation include: Goal 4: Healthy Communities and Ecosystems, Objective 4.5: Enhance Science and Research, Sub-objective 4.5.2: Conduct Relevant Research. The EPA’s Strategic Plan can be found at https://www.epa.gov/ocfo/plan/2003sp.pdf. (PDF, 239pp., 4.75MB)

C. Authority and Regulations
The authority for this RFA and resulting awards is contained in the Safe Drinking Water Act, Section 1442, 42 U.S.C. 300j-1, the Toxic Substances Control Act, Section 10, 15 U.S.C. 2609, the Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, 7 U.S.C. 136r, the Clean Air Act, Section 103, 42 U.S.C. 7403, the Clean Water Act, Section 104, 33 U.S.C., and the Solid Waste Disposal Act, Section 8001, 42 U.S.C. 6901.

D. Specific Research Areas of Interest/Expected Outputs and Outcomes
The purpose of this solicitation is to sponsor research to develop outcome-based environmental health indicators that reliably signal trends in source to exposure, exposure to outcome, and ultimately source to exposure to outcome relationships. An important aspect of this research is the development of statistical and/or other models that use existing environmental (ambient), biological and/or health-related data to quantify these indicators. It is anticipated that these indicators will be sufficiently characterized to act as surrogates of environmental health outcomes and be used to track the impact of environmental management decisions or policy changes. Applications should propose research on one or more of the following:

Relationships between concentrations of chemicals in environmental media (e.g. personal air, dust, and diet) and concentrations of chemicals or metabolites in biological samples (exposure and/or dose biomarkers) that can signal or predict changes in human health outcomes;
Relationships between concentrations of chemicals or metabolites in biological samples and early indicators of disease that can signal or predict changes in human health outcomes;
The temporal and spatial congruence of existing environmental monitoring and health surveillance data systems to determine how they might be combined in assessing the impact of changes in environmental conditions or human exposure on acute and/or chronic health conditions; and

Relationships between an environmental health or exposure indicator and an environmental risk assessment, decision, or policy change implemented at the national, regional, state, or local level. Applications that propose to investigate these relationships are of special interest.

EPA is particularly interested in proposals that incorporate the following:

A clear description of the environmental indicator and the rationale for its selection, including a discussion of the appropriateness of the data sets to be used in its development and evaluation;
The specificity of the proposed approach and/or model and resultant findings to a particular geographic setting, population, or exposure scenario. For example, unique regional and/or seasonal variations of environmental, exposure, or health-related data;
The linkage of the proposed data and the approach and/or model to health related indicators such as reduced exposure, reduced measures of adverse outcomes, reduced disease and/or reduced risk;
The appropriateness of the selected environmental (ambient) or biological data for developing and/or evaluating the approach and/or model proposed for testing;
The applicability and generalizability of particular components of the proposed approach and/or model and findings to other exposure or ambient environmental scenarios; and
A description of the uncertainties associated with the approach/model.

Expected Outputs and Environmental Outcomes

Note to Applicant: The term "output" means an environmental activity or effort, and associated work products, related to a specific environmental goal(s), (e.g. testing a new methodology), that will be produced or developed over a period of time under the agreement. In this context, the term "outcome" refers to the result, effect, or consequence that will occur from the above activit(ies) that is related to an environmental, behavioral, health-related goal. This is not to be confused with the term "health outcome" which was defined earlier in this solicitation.

The expected outputs from this research will be statistical relationships and mathematical models that will relate data on exposure and the early adverse health effects associated with these exposures to health outcomes such as disease incidence and severity and/or mortality. The desired outcomes of this effort involve the use of these indicators by environmental professionals for assessing progress toward established local, regional, and national environmental health goals, thereby proactively identifying opportunities to protect public health.

E. References

United States Environmental Protection Agency, Washington, DC. Draft 2007 EPA Report on the Environment: Technical Document, USEPA, 2006 (https://www.epa.gov/indicators/).
United States Environmental Protection Agency, Washington, DC. 2003 EPA Report on the Environment: Human Health Chapter, USEPA, 2003 (https://www.epa.gov/indicate/roe/html/roeHealthEn.htm).
Centers for Disease Control and Prevention. National Center for Environmental Health, Division of Laboratory Sciences, Atlanta, GA 303421. Third National Report on Human Exposure to Environmental Chemicals. NCEH Pub. No. 05-0570, 2005 (www.cdc.gov/exposurereport).
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, American Journal of Epidemiology 151(11):1091-1102, 2000 (http://www.cheec.uiowa.edu/misc/radon.html).
Goyer RA. Lead Toxicity: Current Concerns, Environmental Health Perspectives 100(1):177-87, 1993 (http://www.ehponline.org/members/1993/100/100010.pdf). (PDF, 11pp., 822KB)
Schwela D. Air Pollution and Health in Urban Areas (Review), Reviews in Environmental Health 15(1-2):13-42, 2000.

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

Awards made under this solicitation are intended to explore the feasibility of using existing data to develop and evaluate environmental health outcome indicators. Therefore, applications that propose the collection of new data will be considered to be non-responsive to this announcement.

II. AWARD INFORMATION

It is anticipated that a total of approximately $3,000,000 will be awarded under this announcement, depending on the availability of funds and quality of applications received. The EPA anticipates funding approximately 6 awards under this RFA. Requests for amounts in excess of a total of $500,000, 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. The EPA reserves the right to reject all applications and make no awards, or make fewer awards than anticipated, under this RFA. The EPA reserves the right, consistent with agency policy and without further competition, to make additional awards under this RFA if additional funding becomes available. Any additional selections for awards will be made no later than 4 months after the original selection decisions. EPA intends to fund grants rather than 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.

III. ELIGIBILITY INFORMATION

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

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

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

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

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

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

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

C. Other
Applications must substantially comply with the application submission instructions and requirements set forth in Section IV of this announcement or they will be rejected. In addition, where a page limitation is expressed in Section IV with respect to parts of the application, pages in excess of the page limit will not be reviewed. Applications must be received by the EPA, or Grants.gov, on or before the solicitation closing date and time in Section IV of this announcement or they will be returned to the sender without further consideration. Also, applications exceeding the funding limits and project terms 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 project's focus must consist of activities within the statutory terms of EPA's financial assistance authorities; specifically, the statute(s) listed above. Generally, a project must address the causes, effects, extent, prevention, reduction, and elimination of air pollution, water pollution, solid/hazardous waste pollution, toxic substances control, or pesticide control. These activities should relate to the gathering or transferring of information or advancing the state of knowledge. Proposals should emphasize this "learning" concept, as opposed to "fixing" an environmental problem via a well-established method. Proposals relating to other topics which are sometimes included within the term "environment" such as recreation, conservation, restoration, protection of wildlife habitats, etc., must describe the relationship of these topics to the statutorily required purpose of pollution prevention and/or control.

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

IV. APPLICATION AND SUBMISSION INFORMATION

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

A. Internet Address to Request Application Package
For paper applications, forms and instructions can be found on the NCER web site: https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms.

For electronic applications, use the application package available at https://apply.grants.gov/forms_apps_idx.html (see "Submission Instructions for Electronic Applications").

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

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

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

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

Executive Order 12372, "Intergovernmental Review of Federal Programs," applies to most EPA programs and assistance agreements, unless the program or assistance agreement supports tribal, training/fellowships (other than Wastewater and Small Water Systems Operator training programs), and research and development (with some exceptions). The SF424 refers to this Executive Order requirement. National research programs are generally exempt from review unless the proposals: (a) require an Environmental Impact Statement (EIS); or (b) do not require an EIS but will be newly initiated at a particular site and require unusual measures to limit the possibility of adverse exposure or hazard to the general public; or (c) have a unique geographic focus and are directly relevant to the governmental responsibilities of a State or local government within that geographic area. To determine whether their state participates in this process, and how to comply, applicants should consult http://www.whitehouse.gov/omb/grants/spoc.html.
Key Contacts
The applicant must complete the "Key Contacts" form as the second page of the application; a Key Contacts continuation page is also available at https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms. The Key Contacts form should also be completed for major sub-agreements (i.e., primary co-investigators). Please make certain that all contact information is accurate.
Table of Contents
Provide a list of the major subdivisions of the application indicating the page number on which each section begins. (Not required for electronic submissions.)
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 indicated in the example format on the website and described below (a-h). Examples of abstracts for current grants may be found on the NCER web site.
1. Funding Opportunity Number:
  TITLE: Development of Environmental Health Outcome Indicators.
  FUNDING OPPORTUNITY NUMBER: EPA-G2007-STAR-A1
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 general phrases such as "research on."
3. Investigators: List the Principal Investigator, then the names and affiliations of each co-investigator who will significantly contribute to the project. Provide a web site URL or an email contact address for additional information.
4. Institution: In the same order as the list of investigators, list the name, city and state of each participating university or other applicant institution. The institution applying for assistance must be clearly identified.
5. Project Period and Location: Show the proposed project beginning and ending dates, and the geographical location(s) 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 project proposed), 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 can be found at: https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms.

Research Plan, Quality Assurance Statement, 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. Describe the policy, planning and/or decision-making that the research is intended to inform. This section should also include any background or introductory information that would help explain the objectives of the study. If this application is to continue research supported by an existing or former assistance agreement awarded under the STAR program, indicate the number of the agreement and provide a brief report of progress and results achieved under it (one to two pages recommended).
  2. Approach/Activities: Outline the research design, methods, and techniques that you intend to use in meeting the objectives stated above (five to ten pages recommended). This section should include the following:
    - A clear description of the environmental indicator and the rationale for its selection, including a discussion of the appropriateness of the data sets to be used in its development and evaluation;
    - The specificity of the proposed approach and/or model and resultant findings to a particular geographic setting, population, or exposure scenario. For example, unique regional and/or seasonal variations of environmental, exposure, or health-related data;
    - The linkage of the proposed data and the approach and/or model to health related indicators such as reduced exposure, reduced measures of adverse outcomes, reduced disease and/or reduced risk;
    - The appropriateness of the selected environmental (ambient) or biological data for developing and/or evaluating the approach and/or model proposed for testing;
    - The applicability and generalizability of particular components of the proposed approach and/or model and findings to other exposure or ambient environmental scenarios; and
    - A description of the uncertainties associated with the approach/model.
  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 would 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 expertise/experience, project schedules, proposed management, interactions with other institutions, etc. Applications for multi-investigator projects must identify project management and the functions of each investigator in each team and describe plans to communicate and share data (one to two pages recommended).
  5. Appendices may be included but must remain within the 15-page limit.
2. Quality Assurance Statement (1 to 3 pages in addition to the 15-page research plan)
  For projects involving environmental data collection or processing, conducting surveys, modeling, method development, or the development of environmental technology (whether hardware-based or via new techniques), provide a Quality Assurance Statement (QAS) regarding the plans for processes that will be used to ensure that the products of the research satisfy the intended project objectives. Follow the guidelines provided below to ensure that the QAS describes a system that complies with ANSI/ASQC E4, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs. Do not exceed three consecutively numbered, 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins.
  
  Address each section below by including the required information, referencing the specific location of the information in the Research Plan, or explaining why the section does not apply to the proposed research.
  1. Identify the individual who will be responsible for the quality assurance (QA) and quality control (QC) aspects of the research along with a brief description of this person's functions, experience, and authority within the research organization. Describe the organization's general approach for conducting quality research. (QA is a system of management activities to ensure that a process or item is of the type and quality needed for the project. QC is a system of activities that measures the attributes and performance of a process or item against the standards defined in the project documentation to verify that they meet those stated requirements.)
  2. Discuss project objectives, including quality objectives, any hypotheses to be tested, and the quantitative and/or qualitative procedures that will be used to evaluate the success of the project. Include any plans for peer or other reviews of the study design or analytical methods.
  3. Address each of the following project elements as applicable:
    1. Collection of new/primary data:
      (Note: In this case the word "sample" is intended to mean any finite part of a statistical population whose properties are studied to gain information about the whole. If certain attributes listed below do not apply to the type of samples to be used in your research, simply explain why those attributes are not applicable.)
      1. Discuss the plan for sample collection and analysis. As applicable, include sample type(s), frequency, locations, sample sizes, sampling procedures, and the criteria for determining acceptable data quality (e.g., precision, accuracy, representativeness, completeness, comparability, or data quality objectives).
      2. Describe the procedures for the handling and custody of samples including sample collection, identification, preservation, transportation, and storage, and how the accuracy of test measurements will be verified.
      3. Describe or reference each analytical method to be used, any QA or QC checks or procedures with the associated acceptance criteria, and any procedures that will be used in the calibration and performance evaluation of the analytical instrumentation.
      4. Discuss the procedures for overall data reduction, analysis, and reporting. Include a description of all statistical methods to make inferences and conclusions, acceptable error rates and/or power, and any statistical software to be used.
    2. Use of existing/secondary data (i.e., data previously collected for other purposes or from other sources):
      1. Describe or reference each analytical method to be used, any QA or QC checks or procedures with the associated acceptance criteria, and any procedures that will be used in the calibration and performance evaluation of the analytical instrumentation.
      2. Discuss the procedures for overall data reduction, analysis, and reporting. Include a description of all statistical methods to make inferences and conclusions, acceptable error rates and/or power, and any statistical software to be used.
    3. Method development:
      (Note: The data collected for use in method development or evaluation should be described in the QAS as per the guidance in section 3A and/or 3B above.)
      
      Describe the scope and application of the method, any tests (and measurements) to be conducted to support the method development, the type of instrumentation that will be used and any required instrument conditions (e.g., calibration frequency), planned QC checks and associated criteria (e.g., spikes, replicates, blanks), and tests to verify the method's performance.
    4. Development or refinement of models:
      (Note: The data collected for use in the development or refinement of models should be described in the QAS as per the guidance in section 3A and/or 3B above.)
      1. Discuss the scope and purpose of the model, key assumptions to be made during development/refinement, requirements for code development, and how the model will be documented.
      2. Discuss verification techniques to ensure the source code implements the model correctly.
      3. Discuss validation techniques to determine that the model (assumptions and algorithms) captures the essential phenomena with adequate fidelity.
      4. Discuss plans for long-term maintenance of the model and associated data.
    5. Development or operation of environmental technology:
      (Note: The data collected for use in the development or evaluation of the technology should be described in the QAS as per the guidance in section 3A and/or 3B above.)
      1. Describe the overall purpose and anticipated impact of the technology.
      2. Describe the technical and quality specifications of each technology component or process that is to be designed, fabricated, constructed, and/or operated.
      3. Discuss the procedure to be used for documenting and controlling design changes.
      4. Discuss the procedure to be used for documenting the acceptability of processes and components, and discuss how the technology will be benchmarked and its effectiveness determined.
      5. Discuss the documentation requirements for operating instructions/guides for maintenance and use of the system(s) and/or process(s).
    6. Conducting surveys:
      (Note: The data to be collected in the survey and any supporting data should be described in the QAS as per the guidance in section 3A and/or 3B above.)
      
      Discuss the justification for the size of the proposed sample for both the overall project and all subsamples for specific treatments or tests. Identify and explain the rational for the proposed statistical techniques (e.g., evaluation of statistical power).
  4. Discuss data management activities (e.g., record-keeping procedures, data-handling procedures, and the approach used for data storage and retrieval on electronic media). Include any required computer hardware and software and address any specific performance requirements for the hardware/software configuration used.
  Page allowances for the following section(s) are in addition to those allowed for the Research Plan and Quality Assurance Statement.
3. References: References cited are in addition to the 15-page Research Plan limit.

Budget and Budget Justification
1. Budget
  Prepare a budget table using the guidance and form found at https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms, and select "All required forms." If a sub-agreement, such as a subcontract with an educational institution, is greater than $25,000 and is included in the application, provide a separate budget and budget justification for the sub-agreement. Include the total amount for the sub-agreement under "Other" in the master budget. Any project containing sub-agreements or subcontracts that constitute more than 40% of the total direct cost of the application will be subject to special review. Additional justification for use of these must be provided, discussing the need for the agreement/contract to accomplish the objectives of the research project.
  
  Please note that institutional cost-sharing is not required. However, if cost-sharing is proposed, a brief statement concerning cost-sharing should be added to the budget justification, and estimated dollar amounts must be included in the appropriate categories in the budget table.
2. Budget Justification (2 pages in addition to the Section 5 page limitations)
  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 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) and specifically identify computers to be purchased or upgraded.
  6. Contractual: Identify each proposed contract for supplies or consultants and specify its purpose and estimated cost. Contracts greater than $25,000 must have a separate itemized budget and budget justification, not to exceed one additional page each, included as part of the application.
  7. Other: List each item in sufficient detail for the EPA to determine the reasonableness of its cost relative to the research to be undertaken. Note that sub-agreements, such as those with other universities for members of the research team, are included in this category. Sub-agreements greater than $25,000 must have a separate itemized budget and budget justification, not to exceed one additional page each, included as part of the application.
  8. Indirect Costs: If indirect costs are included in the budget, indicate the approved rate and base with an explanation of how indirect costs were calculated.
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.
Current and Pending Support
Identify any current and pending financial resources that are intended to support research related to the proposal or that would consume the Principal Investigator's time. Provide information on current and pending support in the form provided at https://www.epa.gov/research-grants/funding-opportunities-how-apply-and-required-forms for each investigator and important co-worker.
Guidelines, Limitations, and Additional Requirements
1. Letters of Intent/Letters of Support
  Letters of intent to provide resources for the proposed research or to specify intended interactions are limited to one brief paragraph committing the availability of a resource (e.g., use of a person's time or equipment) or intended interaction (e.g. sharing of data, as needed consultation) that is described in the Research Plan. Letters of intent are to be included as an addition to the budget justification documents.
  
  All letters that do not commit a resource vital to success of the proposal are considered letters of support. Letters of support, and letters of intent that exceed one brief paragraph, are considered part of the Research Plan and are included in the 15-page Research Plan limit.
  
  Note: these letters must be part of the submitted proposal package to be considered; letters submitted separately will not be read.
2. Funding Opportunity Number (FON):
  At various places in the application, applicants are asked to identify the FON.
  The Funding Opportunity Number for this RFA is: EPA-G2007-STAR-A1
3. Confidentiality
  By submitting an application in response to this solicitation, the applicant grants the EPA permission to make limited disclosures of the application to technical reviewers both within and outside the Agency for the express purpose of assisting the Agency with evaluating the application. Information from a pending or unsuccessful application will be kept confidential to the fullest extent allowed under law; information from a successful application may be publicly disclosed to the extent permitted by law.
  
  In accordance with 40 CFR 2.203, applicants may claim all or a portion of the application/proposal as confidential business information (for example, hypotheses or methodologies contained in the research narrative that the applicant wishes to protect from possible public disclosure). EPA will evaluate confidentiality claims in accordance with 40 CFR Part 2. Applicants must clearly mark applications/proposals or portions of applications/proposals they claim as confidential. If no claim of confidentiality is made, the EPA is not required to make an inquiry to the applicant otherwise required by 40 CFR 2.204(c)(2) prior to disclosure.

C. Submission Dates and Times
For paper copy submissions, the original and two (2) copies of the complete application (3 in all, see below) must be received by NCER no later than 4:00 pm Eastern Time on the solicitation closing date. Electronic applications must be transferred to Grants.gov no later than 4:00 pm Eastern Time on the solicitation closing date.

It should be noted that this schedule might be changed without prior notification because of factors that were not anticipated at the time of announcement. In the case of a change in the required application closing date, a new date will be posted on the NCER web site and a modification posted on www.grants.gov.

Applications received after the closing date will be returned to the sender without further consideration.

Solicitation Closing Date: December 14, 2006, 4:00 pm Eastern Time

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

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

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

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

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

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

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

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

The following address must be used for regular mail:

U.S. Environmental Protection Agency
Peer Review Division (8725F)
Funding opportunity number: EPA-G2007-STAR-A1
1200 Pennsylvania Avenue, NW
Washington, DC 20460

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

U.S. Environmental Protection Agency
Peer Review Division (8725F)
Funding opportunity number: EPA-G2007-STAR-A1
1025 F Street, NW (Room 3500)
Washington, DC 20004
Telephone: (202) 233-0686
Submission Instructions for Electronic Applications
Please read this entire section before attempting an electronic submission through Grants.gov.
1. Preparing for Submission. The appropriate electronic application package available through the http://www.grants.gov site must be used for electronic submissions. In order to view the application package, download the PureEdge viewer (click on “Apply for Grants”, then see “Apply Step 1”). The application package may be quickly accessed from https://apply.grants.gov/forms_apps_idx.html using the appropriate FON. Be sure to download the electronic application package for the appropriate FON. Please register for announcement change notification emails.
  The electronic submission of your application package must be made by an official representative of your institution who is registered with Grants.gov and authorized to sign for Federal assistance. For more information, go to http://www.grants.gov and click on “Get Registered”. Note that the registration process may take a week or longer to complete. If your organization is not currently registered with Grants.gov, please encourage your office to designate an AOR and begin

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The perspectives, information and conclusions conveyed in research project abstracts, progress reports, final reports, journal abstracts and journal publications convey the viewpoints of the principal investigator and may not represent the views and policies of ORD and EPA. Conclusions drawn by the principal investigators have not been reviewed by the Agency.

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