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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

EXPOSURE MEASUREMENT TOOLS FOR ENDOCRINE DISRUPTING CHEMICALS IN MIXTURES

This is the initial announcement of this funding opportunity.

Sorting Code Numbers: 2005-STAR-H1
Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: January 28, 2005
Solicitation Closing Date: April 28, 2005
Application receipt deadline date: April 28, 2005, 4:00 p.m. E.S.T.

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

Technical Contact:
Susan Laessig, Ph. 202-564-5232; email: laessig.susan@epa.gov

Table of Contents:
SUMMARY OF PROGRAM REQUIREMENTS
  Synopsis of Program
  Award Information
  Eligibility Information
  Application Materials
  Contact Person(s)
I. FUNDING OPPORTUNITY DESCRIPTION
  Introduction
  Background
  Specific Research Areas of Interest/Expected Outputs and Outcomes
  References
  Authority and Regulations
II. AWARD INFORMATION
III. ELIGIBILITY INFORMATION
  Eligible applicants
  Cost sharing
IV. APPLICATION AND SUBMISSION INFORMATION
  Internet Address to Request Application Package
  Content and Form of Application Submission
  Submission Instructions for Electronic Applications
  Submission Dates and Times
  Funding Restrictions
  Other Submission Requirements
V. APPLICATION REVIEW INFORMATION
  Criteria
  Review and Selection Process
  Anticipated Announcement and Award Dates
VI. AWARD ADMINISTRATION INFORMATION
  Award Notices
  Administrative and National Policy Requirements
  Reporting
VII. AGENCY CONTACTS

Access Standard STAR Forms and Instructions
View NCER Research Capsules
View previous solicitations
View 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 innovative approaches for measuring the concentrations and activities of endocrine disrupting chemicals (EDCs) in environmental and biological media. The basis of this request for applications is the need to determine how and to what degree human and wildlife populations are exposed to EDCs. Current and previous research is greatly improving our understanding of the effects of EDCs in animals and humans. However, exposure tools are needed in order to measure concentrations and relative activities of EDC mixtures and ultimately to understand the relationships between exposure and adverse effects.

The following areas of research are of interest:

  • Development of analytical methods for measurement of mixtures of EDCs in environmental media at relevant concentrations.
  • Development of rapid chemical or biological detection methods or technologies for environmental exposure monitoring.
  • Development of activity-based biological indicators (androgen, estrogen, and/or thyroid) for assessing EDC exposure in environmental media.

The goal of this research is to develop a suite of methods for EDCs exposure analysis that can be used for environmental or human monitoring studies. Research that combines two or more of the areas of interest is particularly encouraged.

Applications that propose to conduct environmental monitoring or human biomonitoring studies using existing methods will not be considered responsive.

Award Information:

Anticipated Type of Award: Grant
Estimated Number of Awards: Approximately 4-5 awards
Anticipated Funding Amount: Approximately $2.7 million total costs
Potential Funding per Grant: Up to $200,000/year with a duration of 2 or 3 years and no more than a total of $600,000, 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:

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 NCER web site, http://www.epa.gov/ncer/rfa/forms/. To apply electronically, you must also use the application package available at https://apply.grants.gov/forms_apps_idx.html (see “Submission Instructions for Electronic Applications”). If your organization is not currently registered with grants.gov, you need to allow approximately one week to complete the registration process. This registration, and electronic submission of your application, must be performed by an appropriate representative of your organization.

Contact Person(s):

Technical Contact: Susan Laessig; phone: 202-564-5232; email: laessig.susan@epa.gov

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

Electronic Submissions: Bronda Harrison; phone: 202-564-1790; email: harrison.bronda@epa.gov

I. FUNDING OPPORTUNITY DESCRIPTION

Introduction

Chemicals with the potential to interfere with the function of endocrine systems are called endocrine disrupting chemicals (EDCs). Various definitions of EDCs have been proposed. Kavlock et al. (1996) describes an EDC as “An exogenous agent that interferes with the production, release, transport, metabolism, binding, action, or elimination of natural hormones responsible for the maintenance of homeostasis and the regulation of developmental processes in the body.” The World Health Organization has defined an EDC as an exogenous substance or mixture that alters function(s) of the endocrine system and consequently causes adverse health effects in an intact organism, or its progeny, or (sub)populations (IPCS/WHO, 2002). Presently, the relationship(s) between adverse health outcomes and exposure to environmental contaminants is uncertain in part because of a lack of exposure information that can be used to link environmental concentrations to effects.

EPA has a mandate to protect human health and the environment and is studying EDCs in order to reduce scientific uncertainties surrounding the risks of these chemicals to humans and wildlife. In 1996, the U.S. Environmental Protection Agency’s (EPA) Office of Research and Development (ORD) identified EDCs as one of its top six research priorities (USEPA, 1996), and the U.S. Congress directed EPA to develop a screening program to determine whether chemicals have estrogenic or other hormonal effects in humans. Many of the environmental chemicals of concern for endocrine disrupting effects fall under EPA’s regulatory authority to set exposure limits for pesticides, toxic chemicals, or drinking water contaminants and, thus, are of further interest to EPA.

The Endocrine Disruptors research program at EPA is described in ORD’s Endocrine Disruptors Research Plan (USEPA, 1998). ORD has also developed a Multi-Year Plan for Endocrine Disruptors (USEPA, 2003) that identifies the elements of the Research Plan that will be specifically addressed over the next five to ten years. This will be undertaken in EPA’s intramural program, including three national laboratories and one national center, and in the extramural program, through competitive Science to Achieve Results (STAR) grants.

The ORD Multi-Year Plan for Endocrine Disruptors describes three Long-Term Goals.

  1. Provide a better understanding of the science underlying the effects, exposure, assessment, and management of endocrine disruptors. Research includes determining: dose-response relationships, effects of exposure to multiple EDCs, and approaches for assessing and managing risks.

  2. Determine the extent of the impact of endocrine disruptors on humans, wildlife, and the environment. Research includes determining how and to what degree human and wildlife populations are exposed to EDCs, what effects are occurring in exposed human and wildlife populations, and what are the major sources of exposure and environmental fates.

  3. Support EPA’s screening and testing program. Research includes determining whether testing guidelines adequately evaluate potential endocrine-mediated effects.

EDCs are also being used to demonstrate a “proof-of-concept” example as outlined in A Framework for a Computational Toxicology Research Program (USEPA, 2003). The EPA Computational Toxicology Program seeks to improve the Agency’s prioritization of data requirements and risk assessment through the application of new techniques in computational chemistry, molecular biology, and systems biology. The overall goals are to use the modern tools of computational chemistry, molecular biology, and systems biology to improve the efficacy and efficiency of toxicity screening and testing, reduce uncertainty in the source-to-outcome continuum, and enhance quantitative risk assessment.

This request for applications (RFA) addresses key areas of Long Term Goals 1 and 2 described above, and will generate tools and methods that can be applied to monitoring and managing human and wildlife population exposures to EDCs.

The specific EPA Strategic Goal, Objective and Sub-objective that relates to this solicitation includes: Goal 4: Healthy Communities and Ecosystems, Objective: 4.5 Enhance Science and Research, Sub-objective: 4.5.2 Conduct Relevant Research. EPA’s Strategic Plan can be found on the following web page: http://www.epa.gov/ocfo/plan/2003sp.pdf.

Background

Current and previous research is greatly improving our understanding of the effects of EDCs in animals and humans. However, exposure tools are needed in order to measure real-life exposures and to understand the relationships between exposure and adverse effects along the source-to-outcome risk assessment paradigm. Research to develop tools and methods to measure exposure to EDCs is an important component of the EDCs Program at EPA and can lead to improved understanding of the health and ecological risks associated with EDC exposure.

EDCs are known to be present in the environment as a result of human activities, but methods that can be used to estimate exposures to humans and wildlife are limited. EPA-sponsored research on endocrine disruptors has focused up to now on developing methods for identifying chemicals with endocrine activity for the screening and testing program, determining the impacts of EDCs on wildlife, examining the nature of dose-response relationships, and refining the understanding of how known EDCs interact with receptors, cells, and tissues to produce effects. Over the past eight years, EPA, through the extramural STAR program, has funded 38 grants in the area of endocrine disrupting chemicals, but has not previously addressed issues related to human and ecological exposure to EDCs. In order to link effects with exposures in human and wildlife populations, it is necessary to establish that the specific level, duration, and timing of exposures are adequate to produce those effects (Hill, 1965). Methodological research on exposure issues, combined with current efforts in dose-effects research, will allow for more accurate estimations of risk.

General recommendations for research on exposure to EDCs are included in ORD’s Multi-Year Plan for the Endocrine Disruptor Program (2003), the World Health Organization (WHO) Global Assessment of the State-of-the-Science of Endocrine Disruptors (WHO/IPCS, 2002), the WHO/UNEP/ILO International Programme on Chemical Safety Report of the Joint IPCS-Japan Workshop on Endocrine Disruptors: Research Needs and Future Directions (WHO/IPCS, 2004), the National Research Council Hormonally Active Agents in the Environment (NRC, 1999), and in a recent review article (Daston et al., 2003). These recommendations were used to identify potential topics for this RFA.

ORD’s intramural research has contributed to three areas of research on EDC exposure: (1) developing standardized analytical methods for select EDCs (alkylphenols, ethoxylates, E1, E2, E3, EE2, DES, bisphenol A, and trenbolone), (2) developing molecular diagnostic indicators of exposure to estrogenic EDCs in the fathead minnow (Miracle et al., 2004), and (3) testing the application of developed indicators in large scale aquatic environments such as concentrated animal feeding operations, wastewater treatment plants, and pulp mill effluent streams (Hemming et al., 2004). In addition, EPA is collaborating in large-scale human research studies that involve considerable effort to measure individual exposure to pesticides, especially in children. The EPA extramural program aims to promote research in areas not covered by the intramural program and advance new methods and technologies for exposure assessment.

EDCs are chemicals that are distinguished by their mechanism(s) of action on estrogen, androgen, and/or thyroid hormone pathways. Sensitive analytical methods are currently not available for measuring the presence or activity of EDCs in mixtures and environmental media. In addition, it is currently a challenge to estimate environmental exposure to chemical mixtures. Biological activity can be used to develop diagnostic monitoring tools for estimating the impact of multiple EDCs and chemical mixtures on human and wildlife populations. Such activity-based indicators can provide integrated measures of exposure and serve as surrogates of media concentration or internal dose. Methods can include, but are not limited to, bioassay systems for specific modes or mechanisms of action for monitoring complex mixtures or analytical methods for EDCs and their metabolites, including novel technologies such as biosensors and nanotechnology. Methods that have high-throughput capabilities as well as incorporate a high degree of sensitivity, selectivity and cost effectiveness are desirable. New tools that are developed for measuring or monitoring exposures to EDCs and potential effects in populations should be amenable to technology transfer for routine application.

Specific Research Areas of Interest/Expected Outputs and Outcomes

EPA, as part of its Science to Achieve Results (STAR) program, is seeking applications proposing innovative approaches for measuring the concentrations and activities of EDCs in environmental and biological media. The basis of this request for applications is the need to determine how and to what degree human and wildlife populations are exposed to EDCs. Current and previous research is greatly improving our understanding of the effects of EDCs in animals and humans. However, exposure tools are needed in order to measure concentrations and relative activities of EDC mixtures and, ultimately, to understand the relationships between exposure and adverse effects.

The following areas of research are of interest:

  • Development of analytical methods for the measurement of mixtures of EDCs in environmental media at relevant concentrations.

  • Development of rapid chemical or biological detection methods or technologies for environmental exposure monitoring.

  • Development of activity-based biological indicators (androgen, estrogen, and/or thyroid) for assessing EDC exposure in environmental media.

The goal of this research is to develop a suite of methods for estimating exposure to mixtures of EDCs for use in environmental monitoring or human epidemiology studies. Of particular interest are methods that utilize the latest technologies in multi-analyte detection, biosensors, biotechnology, bioengineering, and nanotechnology and incorporate bioassays, microarrays, immunoassays, or genetically engineered organisms. Desirable characteristics include sensitivity, versatility, reproducibility, robustness, efficiency, and cost-effectiveness. For identifying multiple EDCs in mixtures, restricted sensitivity may be needed, whereas for measuring endocrine activity, methods with a broad sensitivity to EDCs may be an advantage. Preferred research will combine two or more of the areas of interest such as rapid analytical- or activity-based detection methods for field- or laboratory-based studies and be amenable to technology transfer. Applications that propose to conduct only environmental monitoring or human biomonitoring studies using existing methods or to develop standard analytical methods for individual chemicals will not be considered responsive.

References

Daston GP, Cook JC, Kavlock RJ (2003). Uncertainties for endocrine disrupters: our view on progress. Toxicol Sci, 74 (2):245-252.

Hemming JM, Allen HJ, Thuesen KA, Turner PK, Waller WT, Lazorchak JM, Lattier D, Chow M, Denslow N, Venables B (2004). Temporal and spatial variability in the estrogenicity of a municipal wastewater effluent. Ecotoxicol Environ Saf, 57(3):303-310.

Hill AB (1965). The Environment and Disease: Association or Causation? Proc R Soc Med, 58:295-300.

WHO/IPCS. 2002. Global Assessment of the State-of-the-Science of Endocrine Disruptors. Eds T. Damstra, S. Barlow, A. Bergman, R. Kavlock. G.Van Der Kraak WHO/PCS/EDC/02.2 World Health Organization, Geneva, Switzerland. 180pp http://ehp.niehs.nih.gov/who/exit EPA

WHO/IPCS. 2004. Report of the Joint IPCS-Japan Workshop on “Endocrine Disruptors: Research Needs And Future Directions”. Available at: http://www.who.int/entity/ipcs/publications/endocrine_disruptors/en/japan_workshop_report.pdfexit EPA.

Kavlock RJ, GP Daston, C DeRosa, P Fenner-Crisp, LE Gray, S Kaatari, G Lucier, M Luster, MJ Mac, C Maczka, R Miller, J Moore, R Rolland, G Scott, DM Sheehan, T Sinks, HA Tilson 1996. Research needs for risk assessment of health and environmental effects of endocrine disruptors: a review of the U.S. EPA-sponsored workshop. Environ. Health Perspect. 104:715–740.

Miracle AL, Toth GP, Lattier DL (2003). The path from molecular indicators of exposure to describing dynamic biological systems in an aquatic organism: microarrays and the fathead minnow. Ecotoxicology, 12(6):457-462.

US Environmental Protection Agency (USEPA). (1996). Strategic plan for the Office of Research and Development. Washington, DC, EPA/600R-96-059 (http://www.epa.gov/osp/strtplan/documents/final.pdf).

US Environmental Protection Agency (USEPA). (1998). ORD’s Endocrine Disruptors Research Plan (http://www.epa.gov/research/htm/documents/ORD-EDR-Feb1998.pdf).

US Environmental Protection Agency (USEPA). (2003). Multi-Year Plan for Endocrine Disruptors (http://www.epa.gov/osp/myp/edc.pdf).

US Environmental Protection Agency (USEPA). (2003). A Framework for a Computational Toxicology Research Program(EPA/600/R-03/065), (http://www.epa.gov/comptox/publications/comptoxframework06_02_04.pdf).

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; Toxic Substances Control Act, Section 10, 15 U.S.C. 2609; and Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, 7 U.S.C. 136r.

II. AWARD INFORMATION

It is anticipated that a total of approximately $2.7 million will be awarded, depending on the availability of funds. EPA anticipates funding approximately 4-5 grants under this RFA. The projected award per grant is $200,000 per year total costs, for up to 3 years. Requests for amounts in excess of a total of $600,000, 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. EPA reserves the right to reject all applications and make no awards under this RFA. EPA reserves the right to offer partial funding of an award made under this RFA. Funding in subsequent years will be contingent upon satisfactory progress. EPA reserves the right to make additional awards under this RFA if additional funding materializes. The additional selections for awards will be made no later than 4 months after the original selection decisions.

III. ELIGIBILITY INFORMATION

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 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 such as a letter of intent from the federal agency involved that commits it to supply the specified service upon funding.

Noncompliance with the formatting instructions (page limits, font size, etc.) set forth in section IV will result in the application being rejected without further review. Applications and initial proposals must be received by EPA on or before the deadline date published in the announcement. 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. See the “Application and Submission Information” section of this RFA for additional information pertaining to administrative requirements.

In addition, applications that propose to conduct environmental monitoring or human biomonitoring studies using existing methods or to develop standard analytical methods for individual chemicals will not be considered responsive.

Potential applicants who are uncertain of their eligibility should contact Tom Barnwell in 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.

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 forms of submission follow.

Internet Address to Request Application Package

Application forms and instructions for applying can be found on the NCER web site at: http://www.epa.gov/ncer/rfa/forms/. In addition, to apply electronically, you must also use the application package available at https://apply.grants.gov/forms_apps_idx.htmlexit EPA (see “Submission Instructions for Electronic Applications”).

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.) will result in the application being rejected without further review. 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 initial 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 Executive Order (E.O.) 12372, “Intergovernmental Review of Federal Programs,” if it affects public health or if an environmental impact statement is required. If applicable, an applicant should consult the office or official designated as the single point of contact in his or her state for more information on the process the state requires to be followed in applying for assistance, if the state has selected the program for review. Additional information regarding E.O 12372 may be found at http://www.whitehouse.gov/omb/grants/spoc.htmlexit EPA.

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 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 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. (A Table of Contents is not required for electronic submissions.)

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 NCER web site.

The abstract, which must belimited 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 (15 pages)

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/Activities/Outputs: 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, Benefits and Outcomes: 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.

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.

F. Budget and Budget Justification

Budget

Prepare a budget table using the guidance and format found at http://www.epa.gov/ncer/rfa/forms/, and 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 if the sub-agreement is greater than $25K. 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 (2 pages in addition to the Section E. page limitations)

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 to the extent permitted by law.

In accordance with 40 CFR 2.203, applicants may claim all or a portion of the application as confidential business information. Confidentiality claims will be evaluated in accordance with 40 CFR 2.205. If no claim of confidentiality is made, EPA is not required to make the inquiry to the applicant normally required by 40 CFR 2.204(c)(2).

Sorting Codes

At various places within the application, applicants are asked to identify the sorting code corresponding to their proposed research topic area in the solicitation.

The sorting code must be placed at the top of the abstract (location is shown in the abstract format, http://www.epa.gov/ncer/rfa/forms), in Box 10 of Standard Form 424, and in the address on the package that is sent to the EPA (see below). For electronic submissions, you must use the appropriate electronic application package (see “Submission Instructions for Electronic Applications”) for the chosen sorting code. Each application must be submitted using a single sorting code.

Data Policy

The application must include a plan to make available all data (including primary and secondary/existing data) from observations, analyses, or model development under an agreement awarded in this program in a format and with documentation such that they can be used by others in the scientific community. The data must be made available to the NCER project officer without restriction and be accompanied by comprehensive metadata documentation adequate for specialists and nonspecialists alike to be able to understand how and where the data were obtained and to evaluate the quality of the data. The data products and their metadata must be provided to the NCER project officer in a standard exchange format no later than the due date of the grant's final report or the publication of the data product's associated results, whichever comes first. Applicants who develop databases containing proprietary or restricted information should provide a strategy, not to exceed two pages, to make the data widely available, while protecting privacy or property rights. These pages are in addition to the 15 pages permitted for the project description.

Letters of Intent/Letters of Support

Letters of intent to provide resources for the proposed research are limited to one brief paragraph committing the availability of a resource (e.g., use of a person's time or equipment) as described in the Research Plan. Letters of intent are to be included as part of the budget justification documents. Letters of support which discuss the proposed research are considered part of the Research Plan and must be included in the 15-page Research Plan limit.

Submission Instructions for Electronic Applications

If you choose to submit your application electronically, you must use the electronic application package available at the http://www.grants.gov/exit EPA web site. In order to view the application package, you will need to download the PureEdge viewer (hyperlink available under “Get Started” then “Get Started Step 2"). You may then access the application package at https://apply.grants.gov/forms_apps_idx.htmlexit EPA using either the CFDA number of 66.509 or Funding Opportunity Number 2005-STAR-H1. It is recommended that you “Register to Receive Notification” of announcement updates.

The actual submission of your application must be made by an official representative of your institution who is registered with http://www.grants.gov/exit EPA (most investigators will not be eligible to submit the application). Please see http://www.grants.gov/exit EPA, “Get Started” for further information. The registration process may take a week or longer. Please check with your Sponsored Programs, or equivalent, office to locate your official representative and see if your institution is registered. If your institution is not currently registered, encourage your official representative to begin the process immediately.

The complete application must be transferred to http://www.grants.gov/exit EPA no later than 4:00 P.M. Eastern Time on the closing date (see “Submission Dates and Times”). An e-mail will be sent by 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 from NCER (not grants.gov) has not been received within 30 days of the submission deadline, then immediately contact the electronic submission support person listed at the end of this section.

Documents must be submitted in Adobe Acrobat PDF format to maintain format integrity. Please submit the required documents as described below.

A. Application for Federal Assistance (SF-424)

1. Complete the form. There are no attachments.

B. EPA Key Contacts Form 5700-54

1. Complete the form.

2. If additional pages are needed, see “E. Other Attachments Form” below.

C. Project Narrative Attachment Form

1. Prepare one document containing the Research Plan followed by the Quality Assurance Statement, label it ResearchPlanQA and submit it as the “Add Mandatory Project Narrative File.”

2. Prepare a document with your abstract, label it Abstract, and submit it as an “Add Optional Project Narrative File.”

3. Prepare one document containing all resumes and related current and pending support information, label it Resumes, and submit it as an “Add Optional Project Narrative File.”

D. Budget Narrative Attachment Form

1. Where possible, prepare one document for your Budget and Budget Justification, label this document BudgetandJustification, and submit it as the “Add Mandatory Budget Narrative.”

2. If you cannot combine your Budget and Budget Justification into one document, prepare one document for each.

a. Label your Budget document Budget and submit it as the “Add Mandatory Budget Narrative.”

b. Label the Budget Justification document BudgetJustification and submit it as an “Add Optional Budget Narrative”document.

E. Other Attachments Form

1. If Key Contacts Continuation pages are needed for the Key Contacts Form 5700-54, combine them into one document labeled ContactsContinuation and submit the document.

2. When submitting letters of intent that are not included in the 15-page limit of the project narrative, combine them into one document, labeled LettersofIntent, and submit it.

3. Other appropriate documents may also be submitted here.

Save your completed application package with two different names before submission to avoid having to re-create the package should you experience submission problems. If you experience submission problems that may result in your application being late, send an email to support@grants.gov and copy the NCER electronic submission support person Bronda Harrison (Phone: 202-564-1790; Email: harrison.bronda@epa.gov).

Submission Dates and Times

For paper copy submissions, the original and two (2) copies of the complete application (3 in all) and one (1) additional copy of the abstract (for a total of 4), must be received by NCER no later than 4:00 P.M. Eastern Time on the closing date assigned to this RFA. Electronic applications must be transferred to http://www.grants.gov/exit EPA no later than 4:00 P.M. Eastern Time on the closing date assigned to this solicitation/RFA. The following is the anticipated 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, a new date will be posted on the NCER web site (http://www.epa.gov/ncer/).

Solicitation Closing Date: April 28, 2005, 4:00 p.m. E.S.T.
Earliest Anticipated Start Date: November 2005

To be considered timely, paper copy applications and initial proposals must be received by the Agency on or before the deadline date published in the RFA; electronic submissions must be transferred to http://www.grants.gov/exit EPA 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.

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 Agency. 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. 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 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 (This section is not relevant when submitting electronically.)

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 two (2) required copies of the application should be secured with paper or binder clips or secure staples.

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

The following address must be used for regular mail:

U.S. Environmental Protection Agency
Peer Review Division (8725F)
Sorting Code: 200X-STAR-XX (replace the "XX" with the appropriate code)
1200 Pennsylvania Avenue, NW
Washington, D.C. 20460

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

U.S. Environmental Protection Agency
Peer Review Division (8725F)
Sorting Code: 200X-STAR-XX (replace the "XX" with the appropriate code)
1025 F Street, NW (Room 3500)
Washington, DC 20004
Phone: (202) 233-0686

V. APPLICATION REVIEW INFORMATION

Criteria

Evaluation of an application’s merit is based on the following criteria which are listed in descending order of importance.

1. a. The originality and creativity of the proposed research, the appropriateness and adequacy of the research methods proposed, and of the Quality Assurance Statement.
b. Is the research approach practical and technically defensible, and can the project be performed within the proposed time period?
c. Will the research contribute to scientific knowledge in the topic area?
d. What are the projected benefits of the proposed activity to society such as by improving the environment or human health?
e. Will the results be disseminated broadly to enhance scientific and technological understanding?
f. 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. Based on their review of each application against the stated criteria, reviewers 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.

For those applications receiving scores of excellent and very good as a result of the peer review, a programmatic review is then conducted by technical experts from within EPA, including ORD and program and Regional offices involved with the science or engineering proposed. The programmatic review considers the relevance of the proposed science to EPA research priorities, program balance, budget, available funds, and considerations such as support for the congressionally mandated Experimental Program to Stimulate Competitive Research (EPSCOR): http://www.epa.gov/ncer/other/. The purpose of the programmatic review is to assure a balanced research portfolio for the Agency and determine which applications to recommend for award. Final funding decisions are made by the NCER Director based on the results of the programmatic review. Applicants who are selected for funding 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: April 28, 2005
Earliest Anticipated Start Date: November 2005

VI. 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. 89-544), as amended, 7 USC 2131-2156. The recipient must also agree to abide by the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training.” (50 Federal Register 20864-20865. May 20,1985)

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. 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.

F. Disputes: Assistance agreement competition-related disputes will be resolved in accordance with the dispute resolution procedures set forth in 70 FR 3629, 3630 (January 26, 2005) which can be found at, http://www.epa.gov/ogd/competition/resolution.htm.

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.

VII. AGENCY CONTACTS

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

Technical Contact: Susan Laessig; phone: 202-564-5232; email: laessig.susan@epa.gov

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

Electronic Submissions: Bronda Harrison; phone: 202-564-1790; email: harrison.bronda@epa.gov


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