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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


Interpretation of Biomarkers Using Physiologically Based Pharmacokinetic Modeling

This is the initial announcement of this funding opportunity.

Funding Opportunity Number: EPA-G2007-STAR-X1

Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: June 14, 2007
Solicitation Closing Date: September 18, 2007, 4:00 pm Eastern Time

Eligibility Contact: Tom Barnwell (barnwell.thomas@epa.gov); phone: 202-343-9862
Electronic Submissions: Thomas O'Farrell (O'Farrell.Thomas@epa.gov); phone: 703-347-8085
Technical Contact: Kacee Deener (deener.kathleen@epa.gov); phone: 703-347-8514

Table of Contents:
Synopsis of Program
Award Information
Eligibility Information
Application Materials
Agency Contacts
A. Introduction
B. Background
C. Authority and Regulations
D. Specific Areas of Interest/Expected Outputs and Outcomes
E. References
F. Special Requirements
A. Eligible Applicants
B. Cost Sharing
C. Other
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
A. Peer Review
B. Programmatic Review
C. Funding Decisions
A. Award Notices
B. Disputes
C. Administrative and National Policy Requirements

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


Synopsis of Program:
The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications proposing the development and/or use of physiologically based pharmacokinetic modeling for the interpretation of biomarker data.

Award Information:
Anticipated Type of Award: Grant or cooperative agreement
Estimated Number of Awards: Approximately 4 awards
Anticipated Funding Amount: Approximately $3 million total for all awards
Potential Funding per Award: Up to a total of $750,000, 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, http://www.epa.gov/ncer/rfa/forms/. To apply electronically, you must use the application package available at Grants.gov (see "Submission Instructions for Electronic Applications" in Section IV). If your organization is not currently registered with Grants.gov, you need to 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.

Agency Contacts:
Eligibility Contact: Tom Barnwell (barnwell.thomas@epa.gov); phone: 202-343-9862
Electronic Submissions: Thomas O'Farrell (O'Farrell.Thomas@epa.gov); phone: 703-347-8085
Technical Contact: Kacee Deener (deener.kathleen@epa.gov); phone: 703-347-8514


A. Introduction
One of the high-priority research areas identified by the EPA Office of Research and Development's (ORD) Human Health Research Strategy is the identification and characterization of biomarkers and development of methods to use them (USEPA, 2003). Biomarkers can help in understanding human exposure, dose, and effects, and the interpretation of biomarker data can help to inform risk assessment. Modeling techniques, including physiologically based pharmacokinetic modeling, can be used to help understand and characterize the target tissue dose and the exposures that are consistent with biomarker data. The EPA currently supports a number of research grants resulting from previous solicitations that deal with the development and validation of biomarkers. Information regarding current and past research on this subject can be found on EPA's National Center for Environmental Research (NCER) web site at http://www.epa.gov/ncer/index.html.

B. Background
Risk assessment is a process used to set environmental and occupational standards limiting exposure to environmental agents with the aim of protecting human health. The risk assessment process involves evaluating information about hazard identification, dose-response, and human exposure in order to characterize the risks associated with exposure to a chemical (Swenberg, 2002). The National Research Council identified four analytical steps necessary for conducting a human health risk assessment: hazard identification, dose-response assessment, exposure assessment, and risk characterization (NRC, 1994). Exposure assessment is the determination or estimation (qualitative or quantitative) of the magnitude, frequency, duration, route, and extent (number of individuals) of exposure to a chemical or other agent. Exposure assessment involves the characterization of the pathways by which an agent is transported through and transformed by the environment, the physical, chemical and biological processes that lead to contact with an agent and the resulting internal dosimetry (USEPA, 1997). The magnitude, timing, and duration of the exposure as well as the absorption, distribution, metabolism and excretion of the toxicant in the body all contribute to the resulting effect in the exposed person. There have been efforts by the EPA over the past several years to address uncertainties in the risk assessment process by conducting and supporting research on exposure assessment, mechanism of action, individual susceptibility, and the development of tools, such as biomarkers, that can be used to characterize exposure, dose and effect. Concurrently, other federal agencies have been collecting biomonitoring data in an effort to characterize exposure to environmental contaminants in the United States.


Biological markers, or biomarkers, are observable properties of an organism that indicate variation in cellular or biochemical components, structure, or function and that can be measured in biologic systems or samples (Bearer, 1998). Biomarkers can be used to estimate prior exposure, to identify changes and effects occurring within an organism, and to assess underlying susceptibility of an organism. They are useful tools for understanding the nature and extent of human exposure from environmental toxicants (Travis, 1993). They can serve as quantitative measures of chemical exposures and biologically effective doses, as well as early warning signals of biologic effect. They can help increase the understanding of the processes by which a chemical is transported and transformed within an organism to produce a dose to a target tissue and the interactions at the cellular or molecular levels leading to a toxic endpoint.

It is useful to envision the processes that link exposure, dose, and effects as a continuum, as shown in figure 1. Events and parameters along the continuum, such as exposure, internal dose, biologically effective dose, early biological effect, altered structure and/or function, and clinical disease can potentially be observed and quantified using biomarkers. Markers of internal dose are direct measures of a toxic chemical or its metabolites in cells, tissues, or body fluids. These markers may integrate multiple portals of entry and fluctuating exposures, and relate time of exposure to internal dose (Strickland, 2002). Markers of biologically effective dose assess the interaction of toxicants with their molecular targets, and markers of early biological effect assess the molecular sequelae of toxicant-cell interactions (Strickland, 2002).

Figure 1 (DeCaprio, 1997)

DeCaprio, 1997

Over the past several years, public health organizations have prioritized the collection of biological samples as a means to determine the types of exposures faced by the American people. The Centers for Disease Control and Prevention (CDC), National Center for Environmental Health, has issued three reports on the exposure of the U.S. population to environmental chemicals using biomonitoring. The Third National Report on Human Exposure to Environmental Chemicals, released in 2005, presents exposure data for the U.S. population for 148 environmental chemicals (CDC, 2005). Additionally, EPA has made a concerted effort to conduct and fund research on the development and validation of new biomarkers in an attempt to better understand exposure, dose, effects, and susceptibility. The ultimate goal in this research has been to decrease uncertainties in risk assessment and to better understand risk.

For the purposes of this RFA, EPA is particularly interested in the exposure-to-dose (target tissue or biologically effective dose) portion of the risk paradigm and in biomarkers that can be used to assess exposure or dose. Biomarkers of susceptibility are also of interest, such as for describing differences in detoxification pathways and population variability in dose metrics.

Uncertainties in Risk Assessment

There are many uncertainties associated with risk assessment, several involving the extrapolation of data, such as from:

  • Dose to dose (high dose in animals to low dose for application to human populations)
  • Route to route (e.g., ingestion versus inhalation)
  • Species to species (animal to human)

(NRC, 1994)

A key to successful extrapolation is “the reliability with which target tissue dose can be predicted in different animal species under a variety of exposure conditions” (Andersen, 2003). Biomarkers may provide information to help understand exposure and target tissue dose, however, the interpretation of biomonitoring data is often a missing factor. Information about pharmacokinetics can be essential to the accurate interpretation of biomarker data (Tan, et al, 2005). Pharmacokinetics (PK) involves the study of the time course of the parent chemical or metabolite concentrations in biological fluids, tissues, and excreta (USEPA, 2005). Compartmental models based on chemical transfer in and out of body compartments can be developed to describe and predict the relationship between administered doses and biologically effective concentrations of parent compounds or metabolites in target tissues. These models, which are based on the anatomy and physiology of mammals and use published comparative physiologic data, are known as physiologically-based pharmacokinetic (PBPK) models (NRC, 1994). PBPK models can be used to interpret biomarker data by estimating the target tissue dose and even the exposure that occurred to result in the measured biomarker level. In this situation, the exposure-to-dose continuum is used in reverse for “dose-to-exposure” estimations (USEPA, 2003). Research in both of these areas – estimation of target tissue dose from biomonitoring data and estimation of exposures using biomonitoring data – has been identified as priorities in the EPA Office of Research and Development’s Human Health Research Strategy (USEPA, 2003).

Physiologically-Based Pharmacokinetic Modeling

The role of PBPK models in informing risk assessment has been described by the EPA’s National Center for Environmental Assessment (NCEA) in their report on Approaches for the Application of Physiologically Based Pharmacokinetic Models and Supporting Data in Risk Assessment (USEPA, 2005, http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=157668). PBPK models can be used to decrease uncertainty in risk assessment in several ways. They can be used for conducting extrapolations, including inter- and intra-species, route-to-route, and high-dose to low-dose extrapolations. PBPK models can be used to convert a potential dose or exposure concentration into a tissue dose that can then be used for risk assessment purposes. Of interest to this RFA, these models can be used to investigate and establish the relationship between biomarker data and potential dose (exposure) through dose reconstruction, as well as the relationship between biomarker levels and target tissue dose of chemicals. This information can help to inform risk characterization (USEPA, 2005).

The specific Strategic Goal and Objective from EPA’s Strategic Plan that relate to this solicitation include: Goal 4: Healthy Communities and Ecosystems and Objective 4.4: Enhance Science and Research. The EPA’s Strategic Plan can be found at http://www.epa.gov/ocfo/plan/2006/entire_report.pdf (PDF) (184 pp, 11.56 MB, about PDF)

C. Authority and Regulations
The authority for this RFA and resulting awards is contained in the Toxic Substances Control Act, Section 10, 15 U.S.C. 2609.

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

D. Specific Research Areas of Interest/Expected Outputs and Outcomes
Note to applicant: The term “output” means an environmental activity or effort, and associated work products, related to a specific environmental goal(s), (e.g., testing a new methodology), that will be produced or developed over a period of time under the agreement. The term “outcome” means the result, effect, or consequence that will occur from the above activit(ies) that is related to an environmental, behavioral, or health-related objective.

The Agency is soliciting research that proposes the development and/or use of physiologically based pharmacokinetic modeling to interpret biomarker data, including existing biomarker data sets. Proposed models, methods, tools, and data should contribute to providing a better scientific understanding of biomarker data and how to interpret it.

There are four areas of research covered by this solicitation:

  1. The development and subsequent use of PBPK models to determine target tissue dose based on human biomarker data (including existing biomarker data, such as from epidemiological or occupational health studies or from biomarker data sets such as the CDC’s National Health and Nutrition Examination Survey, http://www.cdc.gov/nchs/nhanes.htm);
  2. The incorporation of biomarkers of susceptibility (e.g., polymorphisms) into new or existing PBPK models to describe differences in Phase I or Phase II metabolism and population variability in dose metrics;
  3. The development of methods to integrate existing PK models (including PBPK models) and biomarker data to estimate and characterize both absorbed doses and exposures;
  4. The use of other mathematical and statistical methods (in conjunction with PK models) to estimate and characterize the exposure consistent with observed biomarker levels.

Examples of research in the above areas may involve characterization of the target tissue dose for a particular chemical or class of chemicals through the development and use of PBPK models to interpret existing biomarker data (e.g., the CDC’s National Health and Nutrition Examination Survey, http://www.cdc.gov/nchs/nhanes.htm). Research could also involve characterization of exposures consistent with biomarker data through the use of PBPK and other methods and models. Other research could include the incorporation of susceptibility information into new or existing PBPK models to describe differences in metabolism. Specific outputs from research funded through this RFA could include newly developed PBPK models, data supporting the interpretation of existing biomarker data, new methods that can be used to integrate existing PBPK models and biomarker data for the interpretation of those data, and tools that could be used by risk assessors at all levels of government. A potential outcome includes advancing the general scientific understanding of existing biomarker data. The use of innovative research approaches for this RFA is encouraged.

Notes about Relevant Proposals:

  • For the purposes of this RFA, the EPA is interested in the exposure-to-dose portion of the risk paradigm and in interpreting biomarker data that assesses exposure or dose. Information on susceptibility as it affects metabolism and dose is also of interest.
  • The EPA is interested in aggregate and cumulative risk. While not a requirement for the RFA, applicants should be aware that models addressing aggregate (i.e., multiple exposure routes) and cumulative (i.e., multiple chemicals) exposures are desired.
  • EPA is not interested in proposals that focus on volatile organic chemicals, dioxins, or polychlorinated biphenyls. Additionally, EPA is not interested in proposals that focus exclusively on lead or mercury; however, these compounds may be included if the work addresses cumulative risks for a broader group of chemicals.
  • EPA is particularly interested in proposals that focus on semi-volatile, non-persistent chemicals. Chemical classes of particular interest to the EPA (though not a requirement for the RFA) include: pyrethroids, conazoles, n-methyl carbamates, organophosphates, and perfluorinated compounds.

E. References

  1. Andersen, M.E., Toxicokinetic modeling and its applications in chemical risk assessment. Toxicology Letters 138:9-27 (2003).
  2. Bearer, C., Biomarkers in Pediatric Environmental Health: A Cross-Cutting Issue. Environmental Health Perspectives, 103, Supplement 3:813-816 (1998).
  3. DeCaprio, Anthony P., Biomarkers: Coming of Age for Environmental Health and Risk Assessment. Environmental Science and Technology, 31 (7):1837-1847 (1997).
  4. Science and Judgment in Risk Assessment, National Research Council, Committee on Risk Assessment of Hazardous Air Pollutants, Commission on Life Sciences; National Academies Press, 1994.
  5. Strickland, Paul, Introduction to Molecular Epidemiology and Biomarkers. Johns Hopkins Bloomberg School of Public Health, Baltimore, MD (2002).
  6. Swenberg, James A., Gorgeiva, Nadia, Ham, Amy, Koc, Hasan, Morinello, Eric, Ranasinghe, Asoka, Upton, Patricia, Walker, Vernon; Linking Pharmacokinetics and Biomarker Data to Mechanism of Action in Risk Assessment. Human and Ecological Risk Assessment: 8 (6):1315-1338 (2002).
  7. Tan, Cecilia, Liao, Ken, Clewell, Harvey, “Physiologically Based Pharmacokinetic Modeling as a Tool to Interpret Human Biomonitoring Data.” CIIT Activities, 25 (4): 1-8 (2005).
  8. U.S. Centers for Disease Control and Prevention, National Center for Environmental Health. Third National Report on Human Exposure to Environmental Chemicals, (2005) http://www.cdc.gov/exposurereport/.
  9. USEPA, Approaches for the Application of Physiologically-Based Pharmacokinetic Models and Supporting Data in Risk Assessment, EPA/600/R-05/043F (2006), http://cfpub.epa.gov/ncea/cfm/recordisplay.cfm?deid=157668.
  10. USEPA, Exposure Factors Handbook, (1997), http://www.epa.gov/ncea/pdfs/efh/front.pdf (1193 pp, 10.76 MB, about PDF).
  11. USEPA, Office of Research and Development. Human Health Research Strategy, EPA/600/R-02/050 (2003).

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.

Groups of two or more eligible applicants may choose to form a consortium and submit a single application for this assistance agreement. The application must identify which organization will be the recipient of the assistance agreement and which organizations(s) will be subawardees of the recipient.

The application must include a plan (see "Data Plan" in section IV.B.5.c.) to make available to the public all data generated from observations, analyses, or model development (primary data) and any secondary (or existing) data used under an agreement awarded from this RFA. The data must be available in a format and with documentation such that they may be used by others in the scientific community.


It is anticipated that a total of approximately $3 million will be awarded under this announcement, depending on the availability of funds and quality of applications received. The EPA anticipates funding approximately four grants or cooperative agreements under this RFA. Requests for amounts in excess of a total of $750,000, including direct and indirect costs, will not be considered. The total project period requested in an application submitted for this RFA may not exceed three years. The EPA reserves the right to reject all applications and make no awards, or make fewer awards than anticipated, under this RFA. The EPA reserves the right to make additional awards under this announcement, consistent with Agency policy, if additional funding becomes available after the original selections are made. Any additional selections for awards will be made no later than four months after the original selection decisions.

EPA may fund both grants and cooperative agreements under this announcement.

Under a grant, EPA scientists and engineers are not permitted to be substantially involved in the execution of the research. However, EPA encourages interaction between its own laboratory scientists and grant Principal Investigators after the award of an EPA grant for the sole purpose of exchanging information in research areas of common interest that may add value to their respective research activities. This interaction must be incidental to achieving the goals of the research under a grant. Interaction that is "incidental" does not involve resource commitments.

Where appropriate, based on consideration of the nature of the proposed project relative to the EPA's intramural research program and available resources, the EPA will fund cooperative agreements under this announcement. When addressing a research question/problem of common interest, collaborations between scientists and the institution's principal investigators are permitted under a cooperative agreement. These collaborations may include data and information exchange, providing technical input to experimental design and theoretical development, coordinating extramural research with in-house activities, the refinement of valuation endpoints, and joint authorship of journal articles on these activities. Proposals should not identify EPA cooperators or interactions; specific interactions between EPA's investigators and those of the prospective recipient for cooperative agreements will be negotiated at the time of award.


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, found at 2 CFR Part 230. However, nonprofit organizations described in Section 501(c) (4) of the Internal Revenue Code that lobby are not eligible to apply.

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

Federal Agencies may not apply. Federal employees are not eligible to serve in a principal leadership role on an assistance agreement, and may not receive salaries or augment their 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 or project period term described herein will be returned without review. Further, applications that fail to demonstrate a public purpose of support or stimulation (e.g., by proposing research which primarily benefits a Federal program or provides a service for a Federal agency) will not be funded.

To be considered eligible under this RFA, the following additional conditions apply:

  • EPA is not interested in proposals that focus on volatile organic chemicals, dioxins, or polychlorinated biphenyls. Additionally, EPA is not interested in proposals that focus exclusively on lead or mercury; however, these compounds may be included if the work addresses cumulative risks for a broader group of chemicals. Proposals focusing exclusively on these compounds will not be considered for funding.
  • Proposals must address one or more of the four areas of interest described in Section I.D.

In addition, to be eligible for funding consideration, a project's focus must consist of activities within the statutory terms of EPA's financial assistance authorities; specifically, the statute(s) listed in I.C. above. Generally, a project must address the causes, effects, extent, prevention, reduction, and elimination of air pollution, water pollution, solid/hazardous waste pollution; toxic substances control; or pesticide control. 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.


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: http://www.epa.gov/ncer/rfa/forms/.

For electronic applications, use the application package available at Grants.gov (see “Submission Instructions for Electronic Applications”). Note: With the exception of the Budget form (available at http://www.epa.gov/ncer/rfa/forms), all necessary forms are included in the electronic application package.

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; emails to this address will not be accepted. If you do not receive an email acknowledgment within 30 days of the submission closing date, immediately inform the Eligibility Contact shown in this solicitation. Failure to do so may result in your application not being reviewed. See “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.

  1. Standard Form 424

    The applicant must complete Standard Form 424. 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 exit EPA.

    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.

  2. 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 http://www.epa.gov/ncer/rfa/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.

  3. Table of Contents

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

  4. Abstract (1 page)

    The abstract is a very important document in the review process. Therefore, it is critical that the abstract accurately describes the research being proposed and conveys all the essential elements of the research. Also, the abstracts of applications that receive funding will be posted on the NCER web site.

    The abstract should include the information described below (a-h). Examples of abstracts for current grants may be found on the NCER web site.

    1. Funding Opportunity Title and Number for this proposal.
    2. Project Title: Use the exact title of your project as it appears in the application. The title must be brief yet represent the major thrust of the project. Because the title will be used by those not familiar with the project, strike a balance between highly technical words and phrases and more commonly understood terminology. Do not use general phrases such as "research on."
    3. Investigators: 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) where the work will be conducted.
    6. Project Cost: Show the total dollars requested from the EPA (include direct and indirect costs for all years).
    7. Project Summary: Provide three subsections addressing: (1) the objectives of the study (including any hypotheses that will be tested), (2) the experimental approach to be used (a description of the proposed project), and (3) the expected results of the project and how it addresses the research needs identified in the solicitation, including the estimated improvement in risk assessment or risk management that will result from successful completion of the proposed work.
    8. Supplemental Keywords: Without duplicating terms already used in the text of the abstract, list keywords to assist database searchers in finding your research. A list of suggested keywords may be found at: http://www.epa.gov/ncer/rfa/forms.
  5. Research Plan, Quality Assurance Statement, Data Plan and References
    1. Research Plan (15 pages)

      Applications should focus on a limited number of research objectives that adequately and clearly demonstrate that they meet the RFA requirements. Explicitly state the main hypotheses that you will investigate, the data you will create or use, the analytical tools you will use to investigate these hypotheses or analyze these data, and the results you expect to achieve. Research methods must be clearly stated so that reviewers can evaluate the appropriateness of your approach and the tools you intend to use. A statement such as: "we will evaluate the data using the usual statistical methods" is not specific enough for peer reviewers.

      This description must not exceed fifteen (15) consecutively numbered (bottom center), 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins. While these guidelines establish the minimum type size requirements, applicants are advised that readability is of paramount importance and should take precedence in selection of an appropriate font for use in the proposal.

      The description must provide the following information:

      1. Objectives: List the objectives of the proposed research and the hypotheses being tested during the project, and briefly state why the intended research is important and how it fulfills the requirements of the solicitation. This section should also include any background or introductory information that would help explain the objectives of the study. If this application is to expand upon research supported by an existing or former assistance agreement awarded under the STAR program, indicate the number of the agreement and provide a brief report of progress and results achieved under it (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).
      3. Expected Results, Benefits, Outputs, and Outcomes: Describe the results you expect to achieve during the project (outputs) and the potential benefits of the results (outcomes). This section should also discuss how the research results will lead to solutions to environmental problems and improve the public's ability to protect the environment and human health. A clear, concise description will help NCER and peer reviewers 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 (3 pages)

      For projects involving environmental data collection or processing, conducting surveys, modeling, method development, or the development of environmental technology (whether hardware-based or via new techniques), provide a Quality Assurance Statement (QAS) regarding the plans for processes that will be used to ensure that the products of the research satisfy the intended project objectives. Follow the guidelines provided below to ensure that the QAS describes a system that complies with ANSI/ASQC E4, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs. Do not exceed three consecutively numbered, 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins.

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

      Address each applicable section below by including the required information, referencing the specific location of the information in the Research Plan, or explaining why the section does not apply to the proposed research. (Not all will apply.)

      1. Identify the individual who will be responsible for the quality assurance (QA) and quality control (QC) aspects of the research along with a brief description of this 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. Identify the types of secondary data needed to satisfy the project objectives. Specify requirements relating to the type of data, the age of data, geographical representation, temporal representation, and technological representation, as applicable.
          2. Specify the source(s) of the secondary data and discuss the rationale for selection.
          3. Establish a plan to identify the sources of the secondary data in all deliverables/products.
          4. Specify quality requirements and discuss the appropriateness for their intended use. Accuracy, precision, representativeness, completeness, and comparability need to be addressed, if applicable.
          5. Describe the procedures for determining the quality of the secondary data.
          6. Describe the plan for data management/integrity.
        3. Method development:
          (Note: The data collected for use in method development or evaluation should be described in the QAS as per the guidance in section 3A and/or 3B above.)

          Describe the scope and application of the method, any tests (and measurements) to be conducted to support the method development, the type of instrumentation that will be used and any required instrument conditions (e.g., calibration frequency), planned QC checks and associated criteria (e.g., spikes, replicates, blanks), and tests to verify the 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.
    3. Data Plan (2 pages)

      Provide a plan to make all data resulting from an agreement under this RFA available in a format and with documentation/metadata such that they may be used by others in the scientific community. This includes both primary and secondary or existing data, i.e., from observations, analyses, or model development collected or used under the agreement. Applicants who plan to develop or enhance databases containing proprietary or restricted information must provide, within the two pages, a strategy to make the data widely available, while protecting privacy or property rights.

    4. References: References cited are in addition to other page limits (e.g. research plan, quality assurance statement, data plan)
  6. Budget and Budget Justification
    1. Budget

      Prepare a budget table using the guidance and form found at http://www.epa.gov/ncer/rfa/forms/, and select "All required forms." If a subaward, such as a subagreement with an educational institution, is greater than $25,000 and is included in the application, provide a separate budget and budget justification for the subaward. Include the total amount for the subaward under "Other" in the master budget. Any project containing subawards 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 subaward/subcontract to accomplish the objectives of the research project.

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

    2. Budget Justification [2 pages in addition to the Section IV.B.5. page limitations, not including additions under Nos. (6) and (7) below to support contracts and subawards]

      Describe the basis for calculating the personnel, fringe benefits, travel, equipment, supplies, contractual support, and other costs identified in the itemized budget. The budget justification should not exceed two consecutively numbered (bottom center), 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins.

      Budget information should be supported at the level of detail described below:

      1. Personnel: List all staff positions by title. Give annual salary, percentage of time assigned to the project, and total cost for the budget period.
      2. Fringe Benefits: Identify the percentage used and the basis for its computation.
      3. Travel: Specify the estimated number of trips, locations, and other costs for each type of travel. Explain the need for any travel, paying particular attention to travel outside the United States. Include travel funds for annual STAR program progress reviews (estimate for two days in Washington, D.C.) and a final workshop to report on results.
      4. Equipment: Identify all tangible, non-expendable personal property to be purchased that has an estimated cost of $5,000 or more per unit and a useful life of more than one year. (Personal property items with a unit cost of less than $5,000 are considered supplies.)
      5. Supplies: "Supplies" means tangible property other than "equipment." Identify categories of supplies to be procured (e.g., laboratory supplies or office supplies). Specifically identify computers to be purchased or upgraded.
      6. Contractual: Identify each proposed contract for services/analyses or consultants and specify its purpose and estimated cost. Contracts 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 subawards, such as those with other universities for members of the research team, are included in this category. Subawards 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 the indirect costs were calculated.
  7. Resumes

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

  8. Current and Pending Support

    Complete a current and pending support form (provided at http://www.epa.gov/ncer/rfa/forms) for each investigator and important co-worker. Include all current and pending research regardless of source.

  9. Guidelines, Limitations, and Additional Requirements
    1. Letters of Intent/Letters of Support

      Letters of intent to provide resources for the proposed research or to document intended interactions are limited to one brief paragraph committing the availability of a resource (e.g., use of a person's time or equipment) or intended interaction (e.g., sharing of data, as-needed consultation) that is described in the Research Plan. Letters of intent are to be included as an addition to the budget justification documents.

      All letters that do not commit a resource vital to 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: Letters of intent or support must be part of the application; letters submitted separately will not be accepted.

    2. Funding Opportunity Number(s) (FON)
      At various places in the application, applicants are asked to identify the FON.
      The Funding Opportunity Number for this RFA is:
      Interpretation of Biomarkers Using Physiologically Based Pharmacokinetic Modeling, EPA-G2007-STAR-X1
    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 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 or portions of applications they claim as confidential. If no claim of confidentiality is made, the EPA is not required to make an inquiry to the applicant as 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 E. 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. Applications received after the closing date and time will be returned to the sender without further consideration.

It should be noted that this schedule may be changed without prior notification because of factors not anticipated at the time of announcement. In the case of a change in the solicitation closing date, a new date will be posted on the NCER web site (http://www.epa.gov/ncer/) and a modification posted on www.grants.gov.

Solicitation Closing Date: September 18, 2007, 4:00 pm Eastern Time for paper applications, 4:00 pm Eastern Time for electronic submissions

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

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

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

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

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

Funding may be used to provide subgrants or subawards of financial assistance to fund partnerships provided the recipient complies with applicable requirements for subawards or subgrants including those contained in 40 CFR Parts 30 or 31, as appropriate. Successful applicants must compete contracts for services and products and conduct cost and price analyses to the extent required by the procurement provisions of these regulations. The regulations also contain limitations on consultant compensation. Applicants are not required to identify contractors or consultants in their proposal. Moreover, the fact that a successful applicant has named a specific contractor or consultant in the proposal EPA approves does not relieve it of its obligations to comply with competitive procurement requirements. Please note that applicants may not award sole source contracts to consulting, engineering or other firms assisting applicants with the proposal based on the firm's role in preparing the proposal.

Successful applicants cannot use subgrants or subawards to avoid requirements in EPA grant regulations for competitive procurement by using these instruments to acquire commercial services or products from for-profit organizations to carry out its assistance agreement. The nature of the transaction between the recipient and the subawardee or subgrantee must be consistent with the standards for distinguishing between vendor transactions and subrecipient assistance under Subpart B Section .210 of OMB Circular A-133, and the definitions of "subaward" at 40 CFR 30.2(ff) or "subgrant" at 40 CFR 31.3, as applicable. EPA will not be a party to these transactions.

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.

  1. 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: (applicant: place the appropriate number here)
    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: (applicant: place the appropriate number here)
    1025 F Street, NW (Room 3500)
    Washington, DC 20004
    Phone: (202) 233-0686
  2. Submission Instructions for Electronic Applications

    Please read this entire section before attempting an electronic submission through Grants.gov. Note: Submission instructions are updated on an as-needed basis. Please provide your AOR with a copy of the following instructions to avoid submission delays that may occur from the use of outdated instructions.

    1. Preparing for Submission. The appropriate electronic application package available through the http://www.grants.gov site must be used for electronic submissions. Note: With the exception of the Budget form (available at http://www.epa.gov/ncer/rfa/forms), all necessary forms are included in the electronic application package. 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 Authorized Organization Representative (AOR) and begin the registration process as soon as possible. Most submission problems can be avoided by communicating with the AOR well before the solicitation closing date and allowing sufficient time for following the guidance provided below.

    2. Acknowledgement of Receipt. The complete application must be transferred to Grants.gov no later than 4:00 pm Eastern Time on the solicitation closing date (see "Submission Dates and Times"). Grants.gov provides acknowledgements of application receipt that include an on-screen notification of successful initial transfer as well as an e-mail notification of successful transfer from Grants.gov to EPA. While it is advisable to retain copies of these Grants.gov acknowledgements to document submission, the only official documentation that the application has been received by NCER is the e-mail acknowledgement sent by NCER to the Principal Investigator and the Administrative Contact. This email will be sent from receipt.application@epa.gov; email to this address will not be accepted. If an email acknowledgment from NCER (not support@grants.gov) has not been received within 30 days of the solicitation closing date, immediately inform the Eligibility Contact shown in this solicitation. Failure to do so may result in your application not being reviewed.
    3. Application Package Preparation. The application package consists of 1 though 4 below.
      1. On the initial electronic Grant Application Package page, complete the "Application Filing Name" field by entering the Principal Investigator's name, starting with the last name. Note: Applicants do not need to complete the "Competition ID" field.
      2. Application for Federal Assistance (SF 424): Complete the form.
      3. EPA Key Contacts Form 5700-54: Complete the form. If additional pages are needed, see (4) below.
      4. Project Narrative Attachment Form (click on "Add Mandatory Project Narrative"): Attach a single electronic file labeled "Application" that contains the items described in Section IV.B.4. through IV.B.9.a of this solicitation. In order to maintain format integrity, this file must be submitted in Adobe Acrobat PDF. Please review the PDF file for conversion errors prior to including it in the electronic application package; requests to rectify conversion errors will not be accepted if made after the solicitation closing date and time. If Key Contacts Continuation pages (see http://www.epa.gov/ncer/rfa/forms) are needed, place them before the Abstract (IV.B.4.).

      Once the application package has been completed, the "Submit" button should be enabled. If the "Submit" button is not active, please contact Grants.gov for assistance (Telephone: 1-800-518-4726). Investigators should save the completed application package with two different file names before providing it to the AOR to avoid having to re-create the package should submission problems be experienced or a revised application needs to be submitted. Note: Revised applications must be submitted before the solicitation closing date and time.

    4. Submitting the application. The application package must be transferred to Grants.gov by an AOR. The AOR should close all other software before attempting to submit the application package. Click the "submit" button of the application package. Your Internet browser will launch and a sign-in page will appear. Note: Minor problems are not uncommon with transfers to Grants.gov. It is essential to allow sufficient time to follow all trouble-shooting instructions, including contacting Grants.gov, before 4:00 pm Eastern Time on the solicitation closing date.

      A successful transfer will end with an on-screen acknowledgement. For documentation purposes, print or screen capture this acknowledgement. If a submission problem occurs, reboot the computer - turning the power off may be necessary - and re-attempt the submission. If submission problems continue, contact Grants.gov for assistance (Telephone: 1-800-518-4726). Note: Grants.gov issues a "case number" upon a request for assistance.

    5. Transmission Difficulties. If transmission difficulties that result in a late transmission, no transmission, or rejection of the transmitted application are experienced and not resolved by following the above instructions, follow the guidance below. NCER may decide to review the application if it is clearly demonstrated that transmission difficulties were due solely as a result of problems associated with the transfer to Grants.gov. The decision regarding acceptance of the application for review will be made by NCER management and provided to the applicant within ten working days of the request. All e-mails, as described below, are to be sent to Thomas O'Farrell (O'Farrell.Thomas@epa.gov) with the FON in the subject line.
      1. Late transfer due to electronic submission problems: Should electronic submission problems result in the application being transferred to Grants.gov after 4:00 pm but before 5:00pm Eastern Time on the solicitation closing date, send an e-mail documenting the problem and include the Grants.gov case number.
      2. Unsuccessful transfer of application package: If a successful transfer of the application cannot be accomplished even with assistance from Grants.gov due to electronic submission issues, send an e-mail before 5:00pm Eastern Time on the solicitation closing date. Document the problem, include the Grants.gov "case number," and attach the entire application.
      3. Grants.gov rejection of application: If a notification is received from Grants.gov stating that the application has been rejected for reasons other than late submittal, immediately send an email which includes any materials provided by Grants.gov with the entire application attached.


A. Peer Review
All eligible grant applications are reviewed by an appropriate external technical peer review panel comprised of individual experts using the criteria below. This review is designed to evaluate each application according to its scientific merit. Each peer review panel includes non-EPA scientists, engineers, social scientists, and/or economists who are accomplished in their respective disciplines and proficient in the technical subjects they are reviewing. Reviewers are asked to individually assign a score of excellent, very good, good, fair, or poor to each application. EPA translates the average of these individual scores into the final panel review score.

Individual external peer review panel members consider an application’s merit based on the criteria below. Criteria 1-5 are listed in descending order of importance:

  1. Research Proposal (criteria “1a” through “1f” are essentially equal):
    1. The originality and creativity of the proposed research, the appropriateness and adequacy of the proposed research methods, and the Quality Assurance Statement.
    2. Is the research approach practical and technically defensible, and can the project be performed within the proposed time period?
    3. Will the research contribute to scientific knowledge in the topic area?
    4. What are the projected benefits of the proposed activity to society, such as improving the environment or human health?
    5. Will the results be disseminated broadly to enhance scientific and technological understanding?
    6. Is the proposal well prepared with supportive information that is self-explanatory or understandable?
  2. Investigators: The qualifications of the Principal Investigator(s) and other key personnel, including research training, demonstrated knowledge of pertinent literature, experience, and publication records. Will all key personnel make a significant time commitment to the project?
  3. Responsiveness: The responsiveness of the proposal to the research needs identified for the research area. Does the proposal adequately address the objectives and special considerations specified by the RFA?
  4. Facilities and equipment: The availability and/or adequacy of the facilities and equipment proposed for the project. Are there any deficiencies that may interfere with the successful completion of the research?
  5. Budget: 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.

B. Programmatic Review
Applications receiving scores of excellent or very good as a result of the peer review process will then undergo an internal programmatic review, as described below, conducted by technical experts from the EPA, including individuals from the Office of Research and Development (ORD) and program and regional offices involved with the science or engineering proposed. All other applications are automatically declined.

After the peer review, those applicants who received scores of excellent or very good as a result of the peer review process will be asked to provide additional information for the programmatic review pertaining to the proposed Lead Principal Investigator's (PI) "Past Performance and Reporting History." The applicant must provide the EPA Project Officer with information on the proposed Lead PI's past performance and reporting history under prior Federal agency assistance agreements in terms of: (i) the level of success in performing each agreement, and (ii) how progress towards achieving the results intended under each agreement was reported. This information is required only for the proposed Lead PI's performance under Federal assistance agreements initiated within the last three years that were similar in size and scope to the proposed project.

The specific information required for each agreement is shown below, and must be provided within two weeks of EPA's request. A maximum of three pages will be permitted for the response; excess pages will not be reviewed. Note: If no prior past performance information and/or reporting history exists, you will be asked to so state.

  1. Name of Granting Agency.
  2. Grant/Cooperative agreement number.
  3. Grant/Cooperative agreement title.
  4. Brief description of the grant/cooperative agreement.
  5. A description of how the agreement is similar in size and scope to the proposed project and whether or not it was successfully performed; if not successfully performed, provide an explanation.
  6. Information relating to the proposed Lead PI's past performance in reporting on progress towards achieving the expected results (outputs/outcomes) under the agreement. Include the history of submitting timely progress/final technical reports, describe how progress towards achieving the expected results was reported/documented, and if such progress was not being made, provide an explanation of whether, and how, this was reported.
  7. Total (all years) grant/cooperative agreement dollar value.
  8. Project period.
  9. Technical contact (project officer), telephone number, and E-mail address (if available).

The purpose of the programmatic review is to assure an integrated research portfolio for the Agency and help determine which applications to recommend for award. In conducting the programmatic review, the EPA will consider information provided by the applicant and may consider information from other sources, including prior and current grantors and agency files.

The internal programmatic review panel will assess:

  1. The relevance of the proposed science to EPA research priorities.
  2. The proposed Lead PI's past performance (under Federal agency assistance agreements initiated within the last three years that were similar in size and scope to the proposed project) in two areas: First, in successfully performing these prior Federal assistance projects, including whether there is a satisfactory explanation for any lack of success. Second, in reporting progress towards achieving results under these agreements, including the proposed Lead PI's history of submitting timely progress/final technical reports that adequately describe the progress toward achieving the expected results (outputs/outcomes) under the agreements. Any explanation of why progress towards achieving the results was not made will also be considered. Applicants whose proposed Lead PI has no relevant past performance and/or reporting history, or for whom this information is not available, will be evaluated neither favorably nor unfavorably on these elements.
  3. The applicant’s organizational experience.

C. Funding Decisions
Final funding decisions are made by the NCER Director based on the results of the peer review and internal programmatic review. In addition, in making the final funding decisions, the NCER Director may also consider program balance, available funds, and the Congressionally-mandated Experimental Program to Stimulate Competitive Research (EPSCOR) (see http://www.epa.gov/ncer/other/). Applicants selected for funding will be required to provide additional information listed below under "Award Notices." The application will then be forwarded to EPA's grants administration office for award in accordance with the EPA's procedures.


A. Award Notices
Customarily, applicants are notified about evaluation decisions within six months of the solicitation closing date. A summary statement of the scientific review by the peer panel will be provided to each applicant with an award or declination letter.

Applicants to be recommended for funding will be required to submit additional certifications and an electronic version of the revised project abstract. They may also be asked to provide responses to comments or suggestions offered by the peer reviewers, a revised budget, and/or to resubmit their proposal. EPA Project Officers will contact Principal Investigators to obtain these materials. Before or after an award, applicants may be required to provide additional quality assurance documentation.

Non-profit applicants that are recommended for funding under this announcement are subject to pre-award administrative capability reviews consistent with Section 8b., 8c. and 9d. of EPA Order 5700.8 - Policy on Assessing Capabilities of Non-Profit Applicants for Managing Assistance Awards (http://www.epa.gov/ogd/grants/award/5700_8.pdf (9 pp, 33 K, about PDF)). In addition, non-profit applicants that qualify for funding may, depending on the size of the award, be required to fill out and submit to the Grants Management Office the Administrative Capabilities Form with supporting documents contained in Appendix A of EPA Order 5700.8.

The official notification of an award will be made by the Agency's Grants Administration Division. Applicants are cautioned that only a grants officer is authorized to bind the Government to the expenditure of funds; preliminary selection by the NCER Director in the Office of Research and Development does not guarantee an award will be made.

B. Disputes
Disputes related to this assistance agreement competition will be resolved in accordance with the dispute resolution procedures set forth in 70 FR 3629, 3630 (January 26, 2005) which can be found at http://www.epa.gov/ogd/competition/resolution.htm. Questions regarding disputes may be referred to the Eligibility Contact identified below.

C. Administrative and National Policy Requirements
Expectations and responsibilities of NCER grantees and cooperative agreement holders are summarized in this section, although the terms grant and grantee are used. See http://www.epa.gov/ncer/guidance for the full terms and conditions associated with an award, including which activities require prior approval from the EPA.

  1. Meetings: Principal Investigators will be expected to budget for, and participate in, All-Investigators Meetings (also known as progress reviews) approximately once per year with EPA scientists and other grantees to report on research activities and discuss issues of mutual interest.
  2. Approval of Changes after Award: Prior written approval is required from the EPA if there will be a significant change from the work described in the application. Examples of these changes are contained in 40 C.F.R. 30.25. Note: prior written approval is also required from the EPA for incurring costs more than 90 calendar days prior to award.
  3. Human Subjects: A grant applicant must agree to meet all EPA requirements for studies using human subjects prior to implementing any work with these subjects. These requirements are given in 40 C.F.R. § 26. For observational studies involving children or pregnant women or nursing mothers please refer to Subparts B & D of 40 C.F.R. § 26. U.S. Department of Health and Human Services regulations at 45 CFR § 46.101(e) have long required "... compliance with pertinent Federal laws or regulations which provide additional protection for human subjects." EPA’s regulation 40 C.F.R Part 26 is such a pertinent Federal regulation. Therefore, the applicant's Institutional Review Board (IRB) approval must state that the applicant's study meets the EPA's regulations at 40 CFR § 26. No work involving human subjects, including recruiting, may be initiated before the EPA has received a copy of the applicant’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.
  4. Animal Welfare: A grant recipient must agree to comply with the Animal Welfare Act of 1966 (P.L. 89-544), as amended, 7 U.S.C. 2131-2156. The recipient must also agree to abide by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training" (50 Federal Register 20864-20865. May 20, 1985).
  5. Data Access and Information Release: After award, all data (including primary and secondary or existing data) must be made available to the NCER Project Officer without restriction and be accompanied by comprehensive metadata documentation adequate for specialists and non-specialists alike to be able to understand how and where the data were obtained and to evaluate the quality of the data. If requested, the data products and their metadata must be provided to the NCER Project Officer in a standard exchange format no later than the due date of the grant's final report or the publication of the data product's associated results, whichever comes first.

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

    The Office of Management and Budget (OMB) Circular A-110, found at 2 CFR Part 215, has been revised to provide public access to research data through the Freedom of Information Act (FOIA) under some circumstances. Data that are (1) first produced in a project that is supported in whole or in part with federal funds and (2) cited publicly and officially by a federal agency in support of an action that has the force and effect of law (i.e., a regulation) may be accessed through FOIA. If such data are requested by the public, the EPA must ask for it, and the grantee must submit it, in accordance with A-110 and the EPA regulations at 40 C.F.R. 30.36.

  6. Reporting: A grant recipient must agree to provide annual progress reports, with associated summaries, and a final report with an executive summary. The summaries will be posted on NCER’s website.

    A grant recipient must agree to provide copies of any peer reviewed journal article(s) resulting from the research during the project period. In addition, the recipient should notify the EPA Project Officer of any papers published after completion of the grant that were based on research supported by the grant. NCER posts references to all publications resulting from a grant on the NCER web site.

  7. Acknowledgement of EPA Support: EPA’s full or partial support must be acknowledged in journal articles, oral or poster presentations, news releases, interviews with reporters and other communications. Any documents developed under this agreement that are intended for distribution to the public or inclusion in a scientific, technical, or other journal shall include the following statement:
    This publication [article] was developed under STAR Research Assistance Agreement No. __________ awarded by the U.S. Environmental Protection Agency. It has not been formally reviewed by the EPA. The views expressed in this document are solely those of [name of recipient] and the EPA does not endorse any products or commercial services mentioned in this publication.

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

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


Further information, if needed, may be obtained from the EPA officials indicated below. Information regarding this RFA obtained from sources other than these Agency Contacts may not be accurate. Email inquiries are preferred.

Eligibility Contact: Tom Barnwell (barnwell.thomas@epa.gov); phone: 202-343-9862
Electronic Submissions: Thomas O'Farrell (O'Farrell.Thomas@epa.gov); phone: 703-347-8085
Technical Contact: Kacee Deener (deener.kathleen@epa.gov); phone: 703-347-8514

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