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Extramural Research

Funding Opportunities

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

Systems-Based Research for Evaluating Ecological Impacts of Manufactured Chemicals

This is the initial announcement of this funding opportunity.

Funding Opportunity Number:
Systems-Based Research For Evaluating Ecological Impacts Of Manufactured Chemicals, EPA-G2014-STAR-E1
Early Career Awards: Systems-Based Research For Evaluating Ecological Impacts Of Manufactured Chemicals, EPA-G2014-STAR-E2

Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: December 4, 2013
Solicitation Closing Date: March 4, 2014, 11:59:59 pm Eastern Time

Technical Contact: Jayne Michaud (michaud.jayne@epa.gov); phone: 703-305-1968
Electronic Submissions: Todd Peterson (peterson.todd@epa.gov); phone: 703-308-7224
Eligibility Contact: Ron Josephson (josephson.ron@epa.gov); phone: 703-308-0442

Table of Contents:
SUMMARY OF PROGRAM REQUIREMENTS
Synopsis of Program
Award Information
Eligibility Information
Application Materials
Agency Contacts
I. FUNDING OPPORTUNITY DESCRIPTION
A. Introduction
B. Background
C. Authority and Regulations
D. Specific Areas of Interest/Expected Outputs and Outcomes
E. References
F. Special Requirements
II. AWARD INFORMATION
III. ELIGIBILITY INFORMATION
A. Eligible Applicants
B. Cost Sharing
C. Other
IV. APPLICATION AND SUBMISSION INFORMATION
A. Internet Address to Request Application Package
B. Content and Form of Application Submission
C. Submission Dates and Times
D. Funding Restrictions
E. Submission Instructions and Other Submission Requirements
V. APPLICATION REVIEW INFORMATION
A. Peer Review
B. Programmatic Review
C. Human Subjects Research Statement (HSRS) Review
D. Funding Decisions
VI. AWARD ADMINISTRATION INFORMATION
A. Award Notices
B. Disputes
C. Administrative and National Policy Requirements
VII. AGENCY CONTACTS

Access Standard STAR Forms (Forms and Standard Instructions Download Page)
View research awarded under previous solicitations (Funding Opportunities: Archive Page)

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 focusing on integrated, transdisciplinary research that would advance scientific understanding of potential for impacts to ecosystem wellbeing associated with the use of manufactured chemicals.  Specifically, the RFA would solicit proposals for systems-based research to develop and apply innovative metrics and modeling approaches to improve evaluation of ecological resilience and impact analyses, and to support environmental sustainability. Successful proposals will translate emerging and advanced methods, data, and computational tools to address complexity of these systems and distill drivers of adverse outcomes to ecological organisms and populations.

This solicitation provides the opportunity for the submission of applications for projects that may involve human subjects research.  Human subjects research supported by the EPA is governed by EPA Regulation 40 CFR Part 26 (Protection of Human Subjects).  This includes the Common Rule at subpart A and prohibitions and additional protections for pregnant women and fetuses, nursing women, and children at subparts B, C, and D.  Research meeting the regulatory definition of intentional exposure research found in subpart B is prohibited by that subpart in pregnant women, nursing women, and children.  Research meeting the regulatory definition of observational research found in subparts C and D is subject to the additional protections found in those subparts for pregnant women and fetuses (subpart C) and children (subpart D).  All applications must include a Human Subjects Research Statement (HSRS, as described in Section IV.B.5.c), and if the project involves human subjects research, it will be subject to an additional level of review prior to funding decisions being made as described in Sections V.C and V.D of this solicitation.

Guidance and training for investigators conducting EPA-funded research involving human subjects may be obtained here:
Ethics, Regulations, and Policies
Human Subjects Research at the Environmental Protection Agency: Ethical Standards and Regulatory Requirements

In addition to regular awards, this solicitation includes the opportunity for early career awards. The purpose of the early career award is to fund research projects smaller in scope and budget by early career PIs.  Please see Section III of this Request for Applications (RFA) for details on the early career eligibility criteria.

Award Information:
Anticipated Type of Award: Grant or Cooperative Agreement
Estimated Number of Awards: Approximately 6 awards (4 regular, 2 early career)
Anticipated Funding Amount: Approximately $4 million total for all awards
Potential Funding per Award: Up to a total of $800,000 for regular awards and up to a total of $400,000 for early career awards, 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. Special eligibility criteria apply to the early career award portion of this RFA. See full announcement for more details.

Application Materials:
To apply under this solicitation, use the application package available at Grants.gov (for further submission information see Section IV.E. “Submission Instructions and other Submission Requirements”).  The necessary forms for submitting a STAR application will be found on the National Center for Environmental Research (NCER) web site, Forms and Standard Instructions Download Page.
If your organization is not currently registered with Grants.gov, you need to allow approximately one month to complete the registration process. Please note that the registration process also requires that your organization have a DUNS number and a current registration with the System for Award Management (SAM) and the process of obtaining both could take a month or more.  Applicants must ensure that all registration requirements are met in order to apply for this opportunity through grants.gov and should ensure that all such requirements have been met well in advance of the submission deadline.  This registration, and electronic submission of your application, must be performed by an authorized representative of your organization.

If you do not have the technical capability to utilize the Grants.gov application submission process for this solicitation, send a webmail message at least 15 calendar days before the submission deadline to assure timely receipt of alternate submission instructions.  In your message  provide the funding opportunity number and title of the program, specify that you are requesting alternate submission instructions, and provide a telephone number, fax number, and an email address, if available.  Alternate instructions will be emailed whenever possible.  Any applications submitted through alternate submission methods must comply with all the provisions of this Request for Applications (RFA), including Section IV, and be received by the solicitation closing date identified above.

Agency Contacts:
Technical Contact: Jayne Michaud (michaud.jayne@epa.gov); phone: 703-305-1968
Electronic Submissions: Todd Peterson (peterson.todd@epa.gov); phone: 703-308-7224
Eligibility Contact: Ron Josephson (josephson.ron@epa.gov); phone: 703-308-0442

I. FUNDING OPPORTUNITY DESCRIPTION

A. Introduction
One of EPA’s high-priority interests is to support research that will result in a better understanding of organismal and ecosystem vulnerability to chemical exposures in order to support sustainable decisions that minimize risks, and better protect ecological wellbeing. 

In its “Exposure Science in the 21st Century: A Vision and A Strategy” report (NRC 2012a) the National Academies' National Research Council (NRC) notes that recent advances in measurement and computational technologies afford opportunities to study complex systems and to better understand direct and indirect effects of exposures to aquatic and wildlife populations.   Important large scale research activities (About NEON & Mission Exit EPA Click for Disclaimer) are supporting development and synthesis of data on the impacts of climate change, land use change and invasive species on natural resources and biodiversity. These data will combine site-based data with remotely sensed data Exit EPA Click for Disclaimer and existing continental-scale data sets Exit EPA Click for Disclaimer to provide a range of scaled data products that can be used to describe changes in the nation’s ecosystem through space and time.  These emerging data streams in combination with recent advances in mechanistic toxicology (National Ecological Observatory Network (NEON) Exit EPA Click for Disclaimer) provide an opportunity to improve assessment of impacts to ecological systems associated with exposures to manufactured chemicals.

As part of its STAR program, EPA is soliciting proposals for systems-based research to develop and apply innovative metrics and modeling approaches to improve evaluation of ecological resilience and impact analyses, and to support environmental sustainability. Successful proposals will translate emerging and advanced methods, data, and computational tools to address complexity of these systems and distill drivers of adverse outcomes to ecological organisms and populations.

EPA’s Chemical Safety for Sustainability (CSS) Research Program currently supports a number of research programs aimed at development of innovative science to support safe, sustainable design and use of chemicals and materials required to promote environmental wellbeing, as well as to protect vulnerable species and populations.  Strategic objectives of the CSS program include developing the scientific basis to evaluate complex interactions of chemical and biological systems to support environmental sustainability  (Chemical Safety Research).

This solicitation provides the opportunity for the submission of applications for projects that may involve human subjects research.  Human subjects research supported by the EPA is governed by EPA Regulation 40 CFR Part 26 (Protection of Human Subjects).  This includes the Common Rule at subpart A and prohibitions and additional protections for pregnant women and fetuses, nursing women, and children at subparts B, C, and D.  Research meeting the regulatory definition of intentional exposure research found in subpart B is prohibited by that subpart in pregnant women, nursing women, and children.  Research meeting the regulatory definition of observational research found in subparts C and D is subject to the additional protections found in those subparts for pregnant women and fetuses (subpart C) and children (subpart D).  All applications must include a Human Subjects Research Statement (HSRS, as described in Section IV.B.5.c), and if the project involves human subjects research, it will be subject to an additional level of review prior to funding decisions being made as described in Sections V.C and V.D of this solicitation.

Guidance and training for investigators conducting EPA-funded research involving human subjects may be obtained here:
Ethics, Regulations, and Policies
Human Subjects Research at the Environmental Protection Agency: Ethical Standards and Regulatory Requirements

In addition to regular awards, this solicitation includes the opportunity for early career awards. The purpose of the early career award is to fund research projects smaller in scope and budget by early career PIs. Please see Section III of this RFA for details on the early career eligibility criteria. 

B. Background
Environmental sustainability requires healthy populations, communities, and ecosystems. However, chemical risks and effects research have traditionally been based upon adverse biological effects of chemical exposure to individuals.  A more comprehensive assessment of ecological risk is needed to link chemical effects on individuals to those at increasing levels of biological complexity and to evaluate the spatial and temporal context in which chemical exposures occur to better evaluate and minimize potential for impacts.  An integrated understanding of species activities (e.g., migration), physical stressors (e.g., habitat, climate, etc.) and biological factors (e.g., trophic interactions) is required to link individual-level exposures to population-, community- and ecosystem-level consequences. Developing the scientific underpinnings necessary to characterize, understand, and link individual-level exposures to risks at higher levels of organization will facilitate the transformation of ecological risk assessment to support sustainable decisions that minimize unintended consequences of chemical manufacture and use.

The goal of most ecological risk assessments of chemical stressors is to inform risk management.  Risk management is then focused on prevention of unacceptable population- and community-level effects. Ecological risk assessments are usually based on different approaches and models that utilize often limited exposure data and stressor-response relationships.   Reliance on these data can lead to significant uncertainties in predicting population and community level responses.  These uncertainties can be broadly categorized as arising from a lack of understanding of:  

  1. Responses across biological levels of organization,
  2. Differences in response and outcomes among and between species or taxa,
  3. Biologically relevant responses arising from chemical stressors, potentially interacting with other stressors, e.g. land use change and associated habitat loss, impacts on hydrogeology, nutrient loadings; climate change, and
  4. Temporal and spatial distribution of species exposure to chemical stressors. 

The goal of this RFA is to apply systems-based approaches for identifying, addressing, and reducing these uncertainties.

For example, the adverse outcome pathway (AOP) concept provides a reasonable basis from which to construct a coherent systems-based approach to making better predictions of population-level risks of chemicals.  Specifically, AOPs provide a transparent framework for establishing linkages across biological levels of organization that culminate in responses meaningful to risk assessment (Ankley et al. 2010), including population-level impacts (Kramer et al. 2011). An AOP based framework can facilitate cross-species extrapolation of responses to chemicals through data organization/analysis (Perkins et al. 2013), or through inclusion of other empirically based approaches (Raimondo et al. 2010).  It is also well suited to incorporate the translation of laboratory test data to field relevant endpoints through novel modeling approaches (Etterson and Bennett 2013) and can incorporate the interactions between multiple chemical and non-chemical stressors (Hooper et al. 2013; Jackson et al. 2011).

Effective use of an AOP framework for assessing population/community-level chemical risk is directly influenced by characterization of chemical exposure. Hence, the work supported under this RFA may involve integration of state-of-the-art exposure predictions with effects analyses or translators of individuals to population effects.  For example, consideration of spatially-explicit exposure predictions could be a logical avenue to explore.  The resultant integration of exposure and individual, population, or community effects models will provide a basis for understanding and reducing risk assessment uncertainties.

Any number of stressors could be examined for this work. For example, existence of established AOPs and exposure information/models for chemicals that interact with/disturb the vertebrate hypothalamic-pituitary-gonadal/thyroidal axes (often referred to as “endocrine-disruptors”), would be a reasonable group of chemicals to consider (Endocrine Disruptor Screening Program (EDSP)). The output generated by this research should be generalizable, transferrable, and informative for a wide range of species or taxa to predict risks at the regional or national scale. Research focusing on sensitive, commercially, and/or recreationally important species is also desirable.

This solicitation is related to specific strategic goals and objectives of EPA’s Chemical Safety for Sustainability (CSS) National Research Program:

The specific Strategic Goal and Objective from the EPA’s Strategic Plan that relate to this solicitation are:

  • Goal 4: Ensuring the Safety of Chemicals and Preventing Pollution, Objective 4.1: Ensure Chemical Safety

More information can be found in EPA’s FY 2011-2015 Strategic Plan

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, the Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, 7 U.S.C. 136r, the Clean Water Act, Section 104, 33 U.S.C. 1254, and the Clean Air Act, Section 103, 42 U.S.C. 7403.

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

Note that a project’s focus is to consist of activities within the statutory terms of EPA’s financial assistance authorities; specifically, the statute(s) listed above.  Generally, a project must address the causes, effects, extent, prevention, reduction, and elimination of air pollution, water pollution, solid/hazardous waste pollution, toxic substances control, or pesticide control depending on which statute(s) is listed above.  These activities should relate to the gathering or transferring of information or advancing the state of knowledge.  Proposals should emphasize this “learning” concept, as opposed to “fixing” an environmental problem via a well-established method.  Proposals relating to other topics which are sometimes included within the term “environment” such as recreation, conservation, restoration, protection of wildlife habitats, etc., must describe the relationship of these topics to the statutorily required purpose of pollution prevention and/or control.

Applicable regulations include: 40 CFR Part 30 (Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations), 40 CFR Part 31 (Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments) and 40 CFR Part 40 (Research and Demonstration Grants).  Applicable OMB Circulars include: OMB Circular A-21 (Cost Principles for Educational Institutions) relocated to 2 CFR Part 220, OMB Circular A-87 (Cost Principles for State, Local and Indian Tribal Governments) relocated to 2 CFR Part 225, and OMB Circular A-122 (Cost Principles for Non-Profit Organizations) relocated to 2 CFR Part 230.

D. Specific Research Areas of Interest/Expected Outputs and Outcomes
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 or health-related objective.

The Agency is soliciting proposals for developing and applying innovative metrics, methods, and models to efficiently and accurately characterize the interactions between the spatial and temporal distribution of chemicals and ecological receptors, and to predict system-level consequences resulting from individual-level exposures.

Examples of important knowledge gaps requiring study and that may be funded through this RFA include, but are not limited to:

  • What spatial and temporal attributes in landscapes, stressor distribution, and population dynamics most influence risks to organisms exposed to chemical stressors? 
  • Which individual-level exposure endpoints best predict population-level responses? 
  • How can a systems-based approach (e.g., Adverse Outcome Pathway framework) be applied to efficiently and cost-effectively  link molecular-level responses associated to chemical exposure with individual and population level impacts in the context of other  stressors (i.e. changes in habitat, climate, etc.)?
  • What novel, non-invasive methods can be applied to improve the efficiency and efficacy of traditional bioassessments of sensitive, threatened, or endangered species while reducing resource demand?

Examples of research questions that are considered to be responsive to this RFA are listed below.

Research Questions:

Focal area 1: Responses across and within biological levels of organization

  1. How do changes in suborganismal-level endpoints (e.g., molecular, cellular, and tissue-level responses) relate quantitatively to changes in apical endpoints such as survival, growth, and reproduction?
  2. How can we quantify the relationship between changes in apical endpoints and those at higher levels of biological organization (population, community, landscape)?
  3. What data are required, for a given taxon, to extrapolate from apical endpoints to specific measures of population performance with different levels of precision?
  4. For different classes of stressors or groups of chemicals, how well are linkages established across various levels of biological organization and how conserved are those linkages across or between species/taxa?

Focal area 2: Spatio-temporal responses of ecologically sensitive commercially or recreationally important populations exposed to multiple simultaneous stressors

  1. How can we evaluate risk to sensitive or important populations or landscapes due to multiple stressors that vary in time or space, including associated uncertainties?
  2. For different types of species, how can we quantify the spatial and temporal overlap between predicted or measured chemical concentrations, species occurrence or habitat, and other important heterogeneously distributed stressors (e.g., temperature or precipitation fluctuations due to climate change)?
  3. How can these approaches be adapted to address differences in the spatial and temporal scales of ecological risk assessment (e.g., site, region and national scales)?

Expected Outputs:

  • Translation of multiple data streams to inform chemical evaluation and risk-based assessments by the scientific community interested in chemical safety and environmental sustainability.
  • Tools and models that evaluate impacts of chemicals/materials/products to identify critical data needs and support chemical safety and environmental sustainability.

Expected Outcomes:

  • Enhanced predictive capacity for using commonly available data to parameterize key indicators of environmental fate and biological dose to support and improve evaluation of a wide range of chemical compounds by the scientific community interested in chemical safety and environmental sustainability.

To the extent practicable, research proposals must embody innovation and sustainability.  Innovation for the purposes of this RFA is defined as the process of making changes; a new method, custom or device.  Innovative research can take the form of wholly new applications or applications that build on existing knowledge and approaches for new uses.  Research proposals must include a discussion on how the proposed research is innovative (see Section IV.B.5.a).  The concept of sustainability is based on language in the U.S. National Environmental Policy Act of 1969 (NEPA).  This definition is reiterated in Executive Order 13514, Federal Leadership in Environment, Energy, and Economic Performance, stating that the goal of sustainability is to, “create and maintain conditions, under which humans and nature can exist in productive harmony, that permit fulfilling the social, economic, and other requirements of present and future generations.” Research proposals must include a discussion on how the proposed research will seek sustainable solutions that protect the environment and strengthen our communities (see Section IV.B.5.a).  ORD will draw from all of the above-mentioned innovation and sustainability definitions in the review/evaluation process of recommending research proposals (see Section V.A).

E. References
Journals
Ankley, G.T., R.S. Bennett, R.J. Erickson, D.J. Hoff, M.W. Hornung, R.D. Johnson, D.R. Mount, J.W. Nichols, C.L. Russom, P.K. Schmieder, J.A. Serrano, J. E. Tietge and D.L. Villeneuve.  2010.  Adverse outcome pathways: A conceptual framework to support ecotoxicology research and risk assessment.  Environ. Toxicol. Chem. 29, 730-741.

Etterson, M.A. and R. S. Bennett. 2013. Quantifying the effects of pesticide exposure on annual reproductive success of birds. Integr Environ Assess Manage. In print. DOI: 10.1002/ieam.1450. Available at: Quantifying the effects of pesticide exposure on annual reproductive success of birds Exit EPA Click for Disclaimer

Hooper, M.J., G.T. Ankley, D.A. Cristol, L.A. Maryoung, P.D. Noyes and K.E. Pinkerton. 2013. Interactions between chemical and climate stressors: A role for mechanistic toxicology in assessing climate change risks. Environ. Toxicol. Chem. 32, 32-48.

Jackson, A.K., D.C. Evers, M.A. Etterson, A.M. Condon, S.B. Folsom, J. Detweiler,  J. Schmerfeld, and D.A Cristol. 2011. Mercury exposure affects the reproductive success of free-living terrestrial songbird, the Carolina wren (Thryothorus ludovicianus). The Auk. 128: 759-769.

Kramer, V.J., M.A. Etterson, M. Hecker, C.A. Murphy, G. Roesijadi, D.J. Spade, J.A. Spromberg, M. Wang and G.T. Ankley.  2011.  Adverse outcome pathways and risk assessment: Bridging to population level effects.  Environ. Toxicol. Chem. 30, 64-76.

Landis, W.G., J.L. Durda, M.L. Brooks, P.M. Chapman, C.A. Menzie, R.G. Stahl jr., J.L. Stauber. 2013. Ecological Risk Assessment in the context of global climate change. Environmental Toxicology and Chemistry 32(1):79-92.

Moe, S.J., K. De Schamphelaere, W.H. Clements, M.T Sorensen, P.J. Van den Brink, M. Liess. 2013. Combined and interactive effects of global climate change and toxicants on populations and communities. Environmental Toxicology and Chemistry 32(1):49-61.

Perkins, E.J., G.T. Ankley, K.M. Crofton, N. Garcia-Reyero, C.A. LaLone, M.S. Johnson, J.E. Tietge and D.L. Villeneuve. 2013. Current perspectives on the use of alternative species in human health and ecological hazard assessments. Environ. Health Perspect. In Press.

Raimondo, S., C.R. Jackson, M.G. Barron. 2010. Influence of taxonomic relatedness and chemical mode of action in acute interspecies estimation models for aquatic species. Environmental Science and Technology. 44: 7711-7716.

Reports
National Research Council (NRC), 2012a. Science for Environmental Protection: The Road Ahead. Exit EPA Click for Disclaimer National Academies Press, Washington. ISBN 978-0-039-26489-1.

National Research Council (NRC), 2012b. Exposure Science in the 21st Century: A Vision and a Strategy Exit EPA Click for Disclaimer National Academies Press, Washington. ISBN 978-0-039-26468-6.

U.S. Environmental Protection Agency, 2012. Implementation of ORD Strategic Research Plans: A Joint Report of the Science Advisory Board and ORD Board of Scientific Counselors (PDF) (60 pp, 334K) (28 Sept 2012) EPA-SAB-12-012.

Presentations
Stahl, R.G., M.J. Hooper, J.M Babus, W. Clements, A. Fritz, T. Gouin, R. Helm, C. Hickey, W. Landis, S.J. Moe. The influence of global climate change on the scientific foundations and applications of environmental toxicology and chemistry: Introduction to a SETAC international workshop. Environmental Toxicology and Chemistry 32(1):13-19 (2013).

F. Special Requirements
Agency policy and ethical considerations prevent EPA technical staff and managers from providing applicants with information that may create an unfair competitive advantage.  Consequently, EPA employees will not review, comment, advise, and/or provide technical assistance to applicants preparing applications in response to EPA RFAs.  EPA employees cannot endorse any particular application.

Multiple Investigator applications may be submitted as: (1) a single Lead Principal Investigator (PI) application with Co-PI(s) or (2) a Multiple PI application (with a single Contact PI).  If you choose to submit a Multiple PI application, you must follow the specific instructions provided in Sections IV. and V. of this RFA.  For further information, please see the EPA Implementation Plan for Policy on Multiple Principal Investigators (Research Business Models Working Group).

Please note: Early career awards will not accommodate a Multiple PI application. Early career awards shall be submitted as a single Lead PI application.  Special eligibility criteria apply to the early career portion of this RFA. Please see Section III of this RFA for details on the early career eligibility criteria.  The application must include an early career verification (see “Early Career Verification” in Section IV.B.5.e).

This solicitation provides the opportunity for the submission of applications for projects that may involve human subjects research.  There are many scientific and ethical considerations that must be addressed in such studies by the study sponsor and research team, including, but not limited to, those related to recruitment, retention, participant compensation, third-party issues, researcher-participant interactions, researcher-community interactions, communications, interventions, and education.  All such research must comply with the requirements of 40 CFR Part 26, and any human observational exposure studies must also adhere to the principles set forth in the Scientific and Ethical Approaches for Observational Exposure Studies (SEAOES) (EPA/600/R-08/062) (PDF) (133 pp, 1.21 MB) document.  SEAOES, which was published by researchers in EPA and which discusses the principles for the ethical conduct of human research studies, serves as a resource for applicants interested in applying under this solicitation.  References to “SEAOES Principles” in this solicitation refers, in general, to the issues of interest in conducting human subjects research studies that maintain the highest scientific and ethical standards and safety during the conduct of these studies.  All applications must include a Human Subjects Research Statement (HSRS; described in Section IV.B.5.c) and if the project involves human subjects research, it will be subject to an additional level of review prior to funding decisions being made as described in Sections V.C and V.D of this solicitation.

The application shall include a plan (see “Data Plan” in section IV.B.5.d) to make available to the NCER project officer all data generated (first produced under the award) from observations, analyses, or model development used under an agreement awarded from this RFA.  The data must be available in a format and with documentation such that they may be used by others in the scientific community.

These awards may involve the collection of “Geospatial Information,” which includes information that identifies the geographic location and characteristics of natural or constructed features or boundaries on the Earth or applications, tools, and hardware associated with the generation, maintenance, or distribution of such information.  This information may be derived from, among other things, a Geographic Positioning System (GPS), remote sensing, mapping, charting, and surveying technologies, or statistical data.

II. AWARD INFORMATION

It is anticipated that a total of approximately $4 million will be awarded under this announcement, depending on the availability of funds, quality of applications received, and other applicable considerations.  The EPA anticipates funding approximately 6 awards (4 regular, 2 early career) under this RFA.  Requests for amounts in excess of a total of $800,000 for regular awards and $400,000 for early career awards, including direct and indirect costs, will not be considered.  The total project period requested in an application submitted for this RFA may not exceed 3 years. 

The EPA reserves the right to reject all applications and make no awards, or make fewer awards than anticipated, under this RFA.  The EPA reserves the right to make additional awards under this 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 six months after the original selection decisions.

In appropriate circumstances, EPA reserves the right to partially fund proposals/applications by funding discrete portions or phases of proposed projects. If EPA decides to partially fund a proposal/application, it will do so in a manner that does not prejudice any applicants or affect the basis upon which the proposal/application, or portion thereof, was evaluated and selected for award, and therefore maintains the integrity of the competition and selection process.

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

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

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

III. ELIGIBILITY INFORMATION

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

Eligible nonprofit organizations include any organizations that meet the definition of nonprofit in OMB Circular A-122, located at 2 CFR Part 230.  However, nonprofit organizations described in Section 501(c) (4) of the Internal Revenue Code that lobby are not eligible to apply.

Foreign governments, international organizations, and non-governmental international organizations/institutions 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 to the extent authorized by law.  Examples are purchase of satellite data, chemical reference standards, analyses, or use of instrumentation or other facilities not available elsewhere.  A written justification for federal involvement must be included in the application.  In addition, an appropriate form of assurance that documents the commitment, such as a letter of intent from the Federal Agency involved, should be included.

The early career awards will support research performed by PIs with outstanding promise at the Assistant Professor or equivalent level. Principal investigators from applicant institutions applying for the early career portion of the RFA must meet the following additional eligibility requirements:

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

Senior researchers may collaborate in a supporting role for early career awards. Early career applications should not propose significant resources for senior researchers and may not list senior researchers as co-PIs.  The application must include an early career verification (see “Early Career Verification” in Section IV.B.5.e).

Potential applicants who are uncertain of their eligibility should contact Ron Josephson (josephson.ron@epa.gov) in NCER, phone: 703-308-0442.

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

C. Other
Applications must substantially comply with the application submission instructions and requirements set forth in Section IV of this announcement or they will be rejected.  In addition, where a page limitation is expressed in Section IV with respect to parts of the application, pages in excess of the page limit will not be reviewed.  Applications must be submitted through grants.gov or by other authorized alternate means (see Section IV.E. “Submission Instructions and Other Submission Requirements” for further information) on or before the solicitation closing date and time in Section IV of this announcement or they will be returned to the sender without further consideration.  Also, applications exceeding the funding limits or project period term described herein will be returned without review.  Further, applications that fail to demonstrate a public purpose of support or stimulation (e.g., by proposing research which primarily benefits a Federal program or provides a service for a Federal agency) will not be funded. 

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

IV. APPLICATION AND SUBMISSION INFORMATION

Additional provisions that apply to this solicitation and/or awards made under this solicitation, including but not limited to those related to confidential business information, contracts and subawards under grants, and proposal assistance and communications, can be found at Fiscal Year 2010 Competitive Grant Awards.

These, and the other provisions that can be found at the website link, are important, and applicants must review them when preparing applications for this solicitation.   If you are unable to access these provisions electronically at the website above, please communicate with the EPA contact listed in this solicitation to obtain the provisions.

Formal instructions for submission through Grants.gov follow in Section E.

A. Internet Address to Request Application Package
Use the application package available at Grants.gov (see Section E. “Submission Instructions and Other Submission Requirements”).  Note: With the exception of the current and pending support form (available at Forms and Standard Instructions Download Page), all necessary forms are included in the electronic application package.

An email will be sent by NCER to the Lead/Contact PI and the Administrative Contact (see below) to acknowledge receipt of the application and transmit other important information.  The email will be sent from receipt.application@epa.gov; emails to this address will not be accepted.  If you do not receive an email acknowledgment within 30 days of the submission closing date, immediately inform the Eligibility Contact shown in this solicitation.  Failure to do so may result in your application not being reviewed.  See Section E. “Submission Instructions and Other Submission Requirements” for additional information regarding the application receipt acknowledgment.

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

  1. Standard Form 424

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

    Applicants are required to provide a “Dun and Bradstreet Data Universal Numbering System” (DUNS) number when applying for federal grants or cooperative agreements.  Organizations may receive a DUNS number by calling 1-866-705-5711 or by visiting the web site at Dun and Bradstreet Exit EPA Click for Disclaimer.

    Executive Order 12372, “Intergovernmental Review of Federal Programs,” does not apply to the Office of Research and Development's research and training programs unless EPA has determined that the activities that will be carried out under the applicants' proposal (a) require an Environmental Impact Statement (EIS), or (b) do not require an EIS but will be newly initiated at a particular site and require unusual measures to limit the possibility of adverse exposure or hazard to the general public, or (c) have a unique geographic focus and are directly relevant to the governmental responsibilities of a State or local government within that geographic area.

    If EPA determines that Executive Order 12372 applies to an applicant's proposal, the applicant must follow the procedures in 40 CFR Part 29.  The applicant must notify their state's single point of contact (SPOC). To determine whether their state participates in this process, and how to comply, applicants should consult Intergovernmental Review (SPOC List).  If an applicant is in a State that does not have a SPOC, or the State has not selected research and development grants for intergovernmental review, the applicant must notify directly affected State, area wide, regional and local entities of its proposal.

    EPA will notify the successful applicant(s) if Executive Order 12372 applies to its proposal prior to award.

  2. Key Contacts

    The applicant must complete the “Key Contacts” form found in the Grants.gov application package.  An “Additional Key Contacts” form is also available at Forms and Standard Instructions Download Page.  The Key Contacts form should also be completed for major sub-agreements (i.e., primary investigators).  Do not include information for consultants or other contractors.  Please make certain that all contact information is accurate.

    For Multiple PI applications:  The Additional Key Contacts form must be completed (see Section I.F. for further information).  Note: The Contact PI must be affiliated with the institution submitting the application.  EPA will direct all communications related to scientific, technical, and budgetary aspects of the project to the Contact PI; however, any information regarding an application will be shared with any PI upon request.  The Contact PI is to be listed on the Key Contact Form as the Project Manager/Principal Investigator (the term Project Manager is used on the Grants.gov form, the term Principal Investigator is used on the form located on NCER’s web site).  For additional PIs, complete the Major Co-Investigator fields and identify PI status next to the name (e.g., “Name: John Smith, Principal Investigator”).

  3. Table of Contents

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

  4. Abstract (1 page)

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

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

    1. Funding Opportunity Title and Number for this proposal.
    2. Project Title: Use the exact title of your project as it appears in the application.  The title must be brief yet represent the major thrust of the project.  Because the title will be used by those not familiar with the project, use more commonly understood terminology.  Do not use general phrases such as “research on.”
    3. Investigators: For applications with multiple investigators, state whether this is a single Lead PI (with co-PIs) or Multiple PI application (see Section I.F.).  For Lead PI applications, list the Lead PI, then the name(s) of each co-PI who will significantly contribute to the project.  For Multiple PI applications, list the Contact PI, then the name(s) of each additional PI.  Provide a web site URL or an email contact address for additional information.
    4. Institution(s): 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 performance site(s)/geographical location(s) where the work will be conducted.
    6. Project Cost: Show the total funding 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 (outputs/outcomes) 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: Forms and Standard Instructions Download Page.
  5. Research Plan, Quality Assurance Statement, Human Subjects Research Statement, Data Plan, Early Career Verification and References

    1. Research Plan (15 pages)

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

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

      The description must provide the following information:

      1. Objectives: List the objectives of the proposed research and the hypotheses being tested during the project, and briefly state why the intended research is important and how it fulfills the requirements of the solicitation. This section should also include any background or introductory information that would help explain the objectives of the study. If this application is to expand upon research supported by an existing or former assistance agreement awarded under the STAR program, indicate the number of the agreement and provide a brief report of progress and results achieved under it.
      2. Approach/Activities: Outline the research design, methods, and techniques that you intend to use in meeting the objectives stated above.
      3. Innovation: Describe how your project shifts current research or engineering paradigms by using innovative theoretical concepts, approaches or methodologies, instrumentation or interventions applicable to one or more fields of research.
      4. Sustainability: Describe how your project embodies the principles of sustainability and seeks sustainable solutions that protect the environment and strengthen our communities. The sustainability primer provides examples of research activities that promote and incorporate sustainability principles.
      5. 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.
      6. Project Management: Discuss other information relevant to the potential success of the project. This should include facilities, personnel expertise/experience, project schedules with associated milestones and target dates, proposed management, interactions with other institutions, etc. Describe the approach, procedures, and controls for ensuring that awarded grant funds will be expended in a timely and efficient manner and detail how project objectives will be successfully achieved within the grant period. Describe how progress toward achieving the expected results (outputs and outcomes) of the research will be monitored and measured. 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.
      7. 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. EPA Human Subjects Research Statement (HSRS) (6 pages)

      All human research studies conducted or supported by EPA are governed by EPA regulations at 40 CFR Part 26 (Protection of Human Subjects). This includes the Basic Federal Policy for the Protection of Human Research Subjects, also known as the Common Rule, at subpart A and additional prohibitions and special protections for pregnant women, nursing women, and children in research conducted or supported by EPA at subparts B, C, and D. Depending upon the type of research being conducted, additional subparts of 40 CFR Part 26 may be relevant.

      Procedures for the review and oversight of human research subject to 40 CFR Part 26 are also provided in EPA Order 1000.17 Change A1 (PDF) (41 pp, 333 K). These include review of projects for EPA-supported human research by the EPA Human Subjects Research Review Official (HSRRO). EPA Order 1000.17 Change A1 requires preliminary approval by the HSRRO of all proposed EPA-supported human research before the agreement can be entered into. Additional requirements must be met and final approval received from the HSRRO before the research can begin. When reviewing human observational exposure studies, EPA Order 1000.17 Change A1 requires the HSRRO to apply the principles described in the SEAOES (PDF) (133 pp, 1.21 MB) document and grant approval only to studies that adhere to those principles.

      All applications submitted under this solicitation must include a HSRS as described below. Please use the definitions below to determine whether the proposed research involves human subjects, and then prepare a HSRS as explained below in the “HSRS Requirements” section.

      Definitions (from 40 CFR Part 26 Subparts A, B, and C) to determine the involvement of human subjects in proposed research:

      • "Human subject" means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
      • "Intervention" includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes.
      • "Interaction" includes communication or interpersonal contact between investigator and subject.
      • "Private information" includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
      • "Individually identifiable" means the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
      • "Research involving the intentional exposure of a human subject" means a study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject’s participation in the study. Research involving intentional human exposures have additional requirements based upon the 2004 NRC Report “Intentional Human Dosing Studies for EPA Regulatory Purposes” Exit EPA Click for Disclaimer See Sections 9 - 15.
      • "Observational research" means any human research that does not meet the definition of research involving intentional exposure of a human subject.

      Human Subjects Research Statement (HSRS) Requirements

      If the proposed research does not involve human subjects as defined above, provide the following statement in your application package as your HSRS: “The proposed research does not involve human subjects.” Applicants should provide a clear justification about how the proposed research does not meet the definition (for example, all samples come from deceased individuals OR samples are purchased from a commercial source and provided without identifiers, etc.).

      If the proposed research does involve human subjects, then include in your application package a HSRS that addresses each applicable section listed below, referencing the specific location of the information in the Research Plan, providing the information in the HSRS, or explaining why the section does not apply to the proposed research. (Not all will apply.) Please use the definitions provided above to ensure consistency in the interpretation of terminology. Do not exceed six consecutively numbered, 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins.

      NOTE: Before EPA approves any research involving human subjects, the requirements of the regulations at 40 CFR Part 26 must be met. Also, before EPA approves human observational exposure research, EPA will examine it to ensure consistency with the SEAOES Principles. The federal Office for Human Research Protections requires that federally funded human subjects research only be conducted at facilities covered by a Federalwide Assurance (FWA). An FWA is a document that designates the Institutional Review Board that will review and oversee the research, specifies the ethical principles under which the research will be conducted, and names the individuals who will be responsible for the proper conduct of the research. The factors below are not intended to be exhaustive of all those needed for the HSRRO to provide the final approval necessary for research to be conducted, but provide a basis upon which the HSRRO may grant the conditional approval necessary for the funding process to begin.

      Items 1 – 8 must be completed for all studies involving human subjects. (For studies involving intentional exposures, also complete Items 9 -15.)

      1. Human subjects involvement, characteristics, and design.
        1. Describe and justify the proposed involvement of human subjects in the work being proposed.
        2. Describe the characteristics of the subject population, including their anticipated number, age range, and health status if relevant.
        3. Describe and justify the sampling plan, as well as the recruitment and retention strategies and the criteria for inclusion or exclusion of any subpopulations.
        4. Describe the research material that will be obtained from or about living individuals in the form of data, specimens, or records.
        5. List any collaborating sites where human subjects research will be performed, and describe the role of those sites and collaborating investigators in the research.
        6. Describe and justify any compensation being provided to subjects for their participation in the research.
        7. Describe the plan for communicating individual and/or aggregate research results to participants, if relevant.
      2. Potential risks to subjects.
        1. Describe the potential risks to human subjects (physical, psychological, financial, legal, or other) and assess their likelihood and seriousness to the human subjects.
      3. Adequacy of protection against risks.
        1. Describe planned procedures for protecting against or minimizing potential risks and assess their likely effectiveness.
        2. Describe planned procedures for the process of obtaining and maintaining informed consent. Include a description of the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent.
        3. If waiver of some or all of the elements of informed consent or of documentation of consent will be sought, provide justification for the waiver.
        4. Where appropriate, discuss the plans for ensuring necessary medical or professional intervention in the event of adverse effects to subjects.
      4. Protection of vulnerable groups, see 40 CFR Part 26, subparts C & D.
        1. Explain the rationale for the involvement of any vulnerable populations, including pregnant women, fetuses, and children if relevant.
        2. Describe the additional protections in place, if any, for protecting vulnerable populations included in the research.
        3. If children are included in the research, describe the process for obtaining parental permission and child assent if relevant.
      5. Protection of privacy and confidentiality.
        1. Describe how data, specimens, and/or records will be collected, managed, and protected, including at collaborating sites, if any, as well as at the primary site.
        2. Indicate who will have access to individually identifiable private information about human subjects.
        3. Describe any additional procedures for the protection of privacy and confidentiality of the human research subjects.
        4. Discuss any mandatory reporting requirements with the potential to come into play during the conduct of the research and describe how these will be communicated to participants if relevant.
        5. Discuss the potential of the research to obtain information about third parties and describe how this will be handled if it occurs.
      6. Relationship between researcher and community.
        1. If the research will take place in a community setting, describe the procedures in place for defining the community, obtaining its involvement in the research, and establishing and maintaining trust.
      7. Potential benefits of the research to the participants and others.
        1. Discuss the potential benefits of the research to the research participants and others.
        2. Discuss why the risks to subjects are reasonable in relation to the anticipated benefits.
      8. Importance of the knowledge to be gained.
        1. Discuss the importance of the knowledge to be gained as a result of the proposed research.
        2. Discuss why the risks to subjects are reasonable in relation to the importance of the knowledge that reasonably may be expected to result.

        The following sections are to be completed for projects involving the intentional exposure of a human subject. Note that intentional exposure of children, pregnant women or nursing women is prohibited, according to 40 CFR Part 26, subpart B. If your proposal does not involve intentional exposures of humans, you may enter “non-applicable” for Sections 9 – 15.

      9. Projects involving intentional exposure of human subjects should only be considered if they have the potential of providing a clear health or environmental benefit or if acquisition of such information is not obtainable by any other means. In no case should the exposure cause lasting harm to study participants.
        1. Provide justification, in advance of being conducted, that the study could contribute to addressing an important scientific question that cannot be resolved on the basis of animal data or other study;
        2. Discuss how the study is designed in accordance with current scientific standards and practices to i) address the research question, ii) include representative study populations for the endpoint in question, and iii) meet requirements for adequate statistical power;
        3. Discuss how the study will be conducted in accordance with recognized good clinical practices, including appropriate monitoring for safety; and
        4. Confirm that the grantee will report comprehensively to their EPA Project Officer, providing the full study protocol, detailed analyses of the data and report any adverse events promptly.
      10. Value of Studies that Seek to Provide a Potential Public Health or Environmental Benefit
        1. Discuss the constitution of the IRB and their ability to consider whether a study has the potential of providing a clear health or environmental benefit to the community.
      11. Criteria for Scientific and Ethical Acceptability
        1. Confirm that the following necessary conditions for scientifically and ethically acceptable intentional human dosing studies have been satisfied:
          1. prior animal studies and, if available, human observational studies;
          2. a demonstrated need for the knowledge to be obtained from intentional human dosing studies;
          3. justification and documentation of a research design and statistical analysis that are adequate to address an important scientific question, including adequate power to detect appropriate effects;
          4. an acceptable balance of risks and benefits, and minimization of risks to participants;
          5. equitable selection of participants;
          6. free and informed consent of participants; and
          7. review by an appropriately constituted IRB.
      12. Participant Selection Criteria
        1. Discuss how the project design ensures that the following conditions are met in selecting research participants: (i) Selection should be equitable; (ii) Selection of persons from vulnerable populations must be convincingly justified in the protocol, which also must justify the measures to be taken to protect those participants; (iii) Selection of individuals with conditions that put them at increased risk for adverse effects in such studies must be convincingly justified in the protocol, which also must justify the measures that investigators will use to decrease the risks to those participants to an acceptable level.
      13. Payment for Participation
        1. Discuss how IRBs, all relevant review boards, investigators, and research sponsors should ensure that payments to participants in intentional human dosing studies are neither so high as to constitute undue inducement nor so low as to be attractive only to individuals who are socio-economically disadvantaged. Proposed levels of and purposes for remuneration (e.g., time, inconvenience, and risk) should be scrutinized in light of the principles of justice and respect for persons.
      14. Best Practices in Informed Consent
        1. Discuss the proposed process regarding informed consent in intentional human dosing studies and how it compares to best practices.
      15. Compensation for Research-Related Injuries
        1. Discuss how you ensure that participants receive needed medical care for injuries incurred in the study, without cost to the participants.
    4. 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 data first produced under the award, 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.

    5. Early Career Verification (1 page)

      For early career awards, provide the following statement in your application package verifying that you meet the early career eligibility requirements:

      "I verify that:

      1. I hold a doctoral degree in a field related to the research being solicited by the closing date of the RFA;
      2. I am untenured at the closing date of the RFA, and
      3. I am, or expect to be, employed in a tenure-track position (or tenure-track-equivalent position) as an assistant professor (or equivalent title) at an institution in the U.S., its territories, or possessions by the award date."

      Note: For a position to be considered a tenure-track-equivalent position, it must meet all of the following requirements: (1) the employing department or organization does not offer tenure; (2) the appointment is a continuing appointment; (3) the appointment has substantial educational responsibilities; and (4) the proposed project relates to the employee's career goals and job responsibilities as well as to the goals of the department/organization.

    6. References: References cited are in addition to other page limits (e.g. research plan, quality assurance statement).

  6. Budget and Budget Justification

    1. Budget

      Prepare a master budget table using “SF-424A Budget Information for Non-Construction Programs” (aka SF-424A), available in the Grants.gov electronic application package and also at Forms and Standard Instructions Download Page.  Only complete “Section B-Budget Categories”.   Provide the object class budget category (a. - k.) amounts for each budget year under the “Grant Program, Function or Activity” heading.  Each column reflects a separate budget year.  For example, Column (1) reflects budget year 1.  The total budget will be automatically tabulated in column (5).

      If a subaward is included in the application, provide a separate SF-424A and budget justification for the subaward.  Include the total amount for the subaward under “Other” in the master SF-424A. 

      Applicants may not use subagreements to transfer or delegate their responsibility for successful completion of their EPA assistance agreement.  Therefore, EPA expects that subawards or subcontracts should not constitute more than 40% of the total direct cost of the total project budget.  If a subaward/subcontract constitutes more than 40% of the total direct cost, additional justification may be required before award, discussing the need for the subaward/subcontract to accomplish the objectives of the research project.  Please refer to Contracts and Subawards if your organization intends to identify specific contractors, including consultants, and subawardees in your proposal. 

      Please note that institutional cost-sharing is not required.  However, if voluntary cost-sharing is proposed, a brief statement concerning cost-sharing should be added to the budget justification.

    2. Budget Justification [2 pages in addition to the Section IV.B.5. page limitations, not including additions under No. (7) below to support subawards]

      Describe the basis for calculating the personnel, fringe benefits, travel, equipment, supplies, contractual support, and other costs identified in the SF-424A.  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, total cost for the budget period, and project role.  Compensation paid for employees engaged in grant activities must be consistent with payments for similar work within the applicant organization.  Note that for salaries to be allowable as a direct charge to the award, a justification of how that person will be directly involved in the project must be provided. General administrative duties such as answering telephones, filing, typing, or accounting duties are not considered acceptable.

        Below is a sample computation for Personnel:

        Position/Title Annual Salary % of Time Assigned to Project Cost
        Project Manager $70,000 50% $ 35,000
        Env. Specialist $60,000 100% $ 60,000
        Env. Health Tech $45,000 100% $ 45,000
        Total Personnel $140,000

        Note this budget category is limited to persons employed by the applicant organization ONLY.  Those employed elsewhere are classified as subawardees, contractors or consultants. Contractors and consultants should be listed under the “Contractual” budget heading while subawards made to eligible subrecipients are listed under the “Other” budget heading.

      2. Fringe Benefits: Identify the percentage used and the basis for its computation. Fringe benefits are for the personnel listed in budget category (1) above and only for the percentage of time devoted to the project. Fringe benefits include but are not limited to the cost of leave, employee insurance, pensions and unemployment benefit plans.  The applicant should not combine the fringe benefit costs with direct salaries and wages in the personnel category.

      3. Travel: Specify the estimated number of trips, purpose of each trip, number of travelers per trip, destinations, 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.

        Below is a sample computation for Travel:

        Purpose of Travel Location Item Computation Cost
        EPA STAR Progress Review DC Lodging 4 people x $100 per night
        x 2 nights
        $800
        Airfare 4 people x $500 round trip $2,000
        Per Diem 4 people x $50 per day
        x 2 days
        $400
        Total Travel $3,200

      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. Details such as the type of equipment, cost, and a brief narrative on the intended use of the equipment for project objectives are required. Each item of equipment must be identified with the corresponding cost. General-purpose equipment (office equipment, etc.) must be justified as to how it will be used on the project. (Property items with a unit cost of less than $5,000 are considered supplies.)

      5. Supplies: “Supplies” means tangible property other than “equipment.” Identify supplies to be used under the project.  This may include: software, office supplies, and laboratory supplies such as reagents, chemicals and glassware. Specifically identify computers to be purchased or upgraded.

      6. Contractual: Specify the amount you anticipate expending for services/analyses or consultants and specify the purpose of the contracts and estimated cost.  Any procurement of services from individual consultants or commercial firms (including space for workshops) must comply with the competitive procurement requirements of 40 CFR Part 30.40-30.48 or 40 CFR 31.36, as appropriate. Please see Contracts and Subawards for more details. 

        Examples of Contractual costs include:

        1. Consultants – Consultants are individuals with specialized skills who are paid at a daily or hourly rate. EPA’s participation in the salary rate (excluding overhead) paid to individual consultants retained by recipients or by a recipient's contractors or subcontractors is limited to the maximum daily rate for a Level IV of the Executive Schedule (formerly GS-18), to be adjusted annually.
        2. Equipment Rental – When there is a need to rent equipment for use on the project, provide information on the type of equipment to be rented, the purpose or use on the project, the length of time needed and the rental rate. Renting or leasing of equipment will require a lease vs. purchase cost analysis prior to approval.
        3. Facility Rental – When it is necessary to rent office or other facilities spaces for project implementation, and the space(s) are located off-site from the organization’s main facility in space not owned by the applicant organization, the cost of the rent may be charged against the award as a contractual expense if the space is used specifically for the project. The budget justifications should provide details on the monthly rental charge and if the rent is pro-rated to the project.
        4. Service or Maintenance Contracts – Costs should be in direct correlation to the use of the equipment for the project (i.e., if a particular machine is used 50% of the time for the project, the project should only be charged 50% of the service/maintenance costs). Provide details of the type of equipment and the amount of the service contract to be paid from EPA funds.
        5. Speaker/Trainer Fees – Information on speakers should include the fee and a description of the services they are providing.
      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. “Other” items may include publication costs, long distance telephone charges, and photocopying costs.  Note that subawards, such as those with other universities for members of the research team, are included in this category. Subawards must have a separate 424A and budget justification, not to exceed one additional page each. Subawards may not be used to acquire services from consultants or commercial firms. Please see Contracts and Subawards for more details.  

      8. Indirect Costs: Indirect costs are those incurred by the applicant for a common or joint purpose that benefit more than one cost objective or project, and are not readily assignable to specific cost objectives or projects as a direct cost. In order for indirect costs to be allowable, the applicant must have a negotiated indirect cost rate (e.g., fixed, predetermined, final or provisional), or must have submitted a proposal to their cognizant agency. If indirect costs are included in the budget, identify the cognizant agency and the approved indirect rate.  If your organization does not have a cognizant agency, please note that in the budget justification and provide a brief explanation for how you calculated your indirect cost rate. 

  7. Resumes

    Provide resumes for each investigator and important co-worker.  You may include resumes from staff of subawardees such as universities.  Do not include resumes of consultants or other contractors. 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 Forms and Standard Instructions Download Page) for
    each investigator and important co-worker.  Do not include current and pending support for consultants or other contractors.  Include all current and pending research regardless of source.

    Note to all prospective applicants requiring multiple Current and Pending Support Form pages: Due to a limitation in Adobe Acrobat's forms functionality, additional pages cannot be directly inserted into the original PDF form and preserve the form data on the subsequent pages. Multiple page form submissions can be created in Acrobat 8 and later using the "PDF Package" option in the "Create PDF from Multiple Files" function. If you have an earlier version of Adobe Standard or Professional, applicants will need to convert each PDF page of the form to an EPS (Encapsulated Post Script) file before creating the PDF for submission. The following steps will allow applicants with earlier versions of Adobe Standard or Professional to create a PDF package:

    1. Populate the first page of the PDF, and save it as a EPS (Encapsulated Post Script) file.
    2. Reopen the form, and populate it with the data for page 2. Save this page as a different EPS file. Repeat for as many pages as necessary.
    3. Use Acrobat Distiller to convert the EPS files back to PDF.
    4. Open Acrobat Professional, and combine the individual pages into a combined PDF file.
  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.  EPA employees are not permitted to provide letters of intent for any application.

      Letters of support do not commit a resource vital to the success of the proposal. A letter of support is written by businesses, organizations, or community members stating their support of the applicant's proposed project.  EPA employees are not permitted to provide letters of support for any application.

      Note:  Letters of intent or support must be part of the application; letters submitted separately will not be accepted.  Any letter of intent or support that exceeds one brief paragraph (excluding letterhead and salutations), is considered part of the Research Plan and is included in the 15-page Research Plan limit.  Any transactions between the successful applicant and parties providing letters of intent or support financed with EPA grant funds are subject to the contract and subaward requirements described here Contracts and Subawards.

    2. Funding Opportunity Number (FON)

      At various places in the application, applicants are asked to identify the FON. 

      The Funding Opportunity Numbers for this RFA are:

      SYSTEMS-BASED RESEARCH FOR EVALUATING ECOLOGICAL IMPACTS OF MANUFACTURED CHEMICALS, EPA-G2014-STAR-E1   

      Early Career Awards: SYSTEMS-BASED RESEARCH FOR EVALUATING ECOLOGICAL IMPACTS OF MANUFACTURED CHEMICALS, EPA-G2014-STAR-E2  

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

    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.

C. Submission Dates and Times
Applications must be transferred to Grants.gov no later than 11:59:59 pm Eastern Time on the solicitation closing date.  Applications transferred after the closing date and time will be returned to the sender without further consideration.  EPA will not accept any changes to applications after the closing date.

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 (Funding Opportunities) and a modification posted on Grants.gov. 

Solicitation Closing Date: March 4, 2014, 11:59:59 pm Eastern Time (applications must be submitted to Grants.gov by this time, see Section IV.E “Submission Instructions and Other Submission Requirements” for further information).

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

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

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

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

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

E. Submission Instructions and Other Submission Requirements
Please read this entire section before attempting an electronic submission through Grants.gov. 

If you do not have the technical capability to utilize the Grants.gov application submission process for this solicitation, send a webmail message at least 15 calendar days before the submission deadline to assure timely receipt of alternate submission instructions.  In your message  provide the funding opportunity number and title of the program, specify that you are requesting alternate submission instructions, and provide a telephone number, fax number, and an email address, if available.  Alternate instructions will be emailed whenever possible.  Any applications submitted through alternate submission methods must comply with all the provisions of this RFA, including Section IV, and be received by the solicitation closing date identified above.

Note:  Grants.gov submission instructions are updated on an as-needed basis.  Please provide your Authorized Organizational Representative (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 electronic submission of your application must be made by an official representative of your institution who is registered with Grants.gov and is authorized to sign applications for Federal assistance. For more information on the registration requirements that must be completed in order to submit an application through grants.gov, go to Grants.gov and click on “Applicants” on the top of the page and then go to the “Get Registered” link on the page. If your organization is not currently registered with Grants.gov, please encourage your office to designate an Authorized Organization Representative (AOR) and ask that individual to begin the registration process as soon as possible. Please note that the registration process also requires that your organization have a DUNS number and a current registration with the System for Award Management (SAM) and the process of obtaining both could take a month or more.  Applicants must ensure that all registration requirements are met in order to apply for this opportunity through grants.gov and should ensure that all such requirements have been met well in advance of the submission deadline.  Registration on grants.gov, SAM.gov, and DUNS number assignment is FREE.

    To begin the application process under this grant announcement, go to Grants.gov and click on “Applicants” on the top of the page and then “Apply for Grants” from the dropdown menu and then follow the instructions accordingly. Please note: To apply through grants.gov, you must use Adobe Reader software and download the compatible Adobe Reader version. For more information about Adobe Reader, to verify compatibility, or to download the free software, please visit Adobe Reader Compatibility

    You may also be able to access the application package for this announcement by searching for the opportunity on Grants.gov.   Go to Grants.gov and then click on “Search Grants” at the top of the page and enter the Funding Opportunity Number, EPA-G2014-STAR-E1 or EPA-G2014-STAR-E2, or the CFDA number that applies to the announcement (CFDA 66.509), in the appropriate field and click the Search button. Alternatively, you may be able to access the application package by clicking on the Application Package button at the top right of the synopsis page for the announcement on Grants.gov.  To find the synopsis page, go to Grants.gov and click “Browse Agencies” in the middle of the page and then go to “Environmental Protection Agency” to find the EPA funding opportunities.

  2. Acknowledgement of Receipt.  The complete application must be transferred to Grants.gov no later than 11:59:59 pm Eastern Time on the solicitation closing date (see “Submission Dates and Times”).  Applications submitted through grants.gov will be time and date stamped electronically.  Grants.gov provides an on-screen notification of successful initial transfer as well as an email 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 email acknowledgement sent by NCER to the Lead/Contact PI and the Administrative Contact.  This email will be sent from receipt.application@epa.gov; emails to this address will not be accepted.  If an email acknowledgment from receipt.application@epa.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.  Your organization’s AOR must submit your complete application package electronically to EPA through Grants.gov (Grants.gov) no later than March 4, 2014, 11:59:59 pm Eastern Time. Please allow for enough time to successfully submit your application process and allow for unexpected errors that may require you to resubmit.    

    Please submit all of the application materials described below using the grants.gov application package that you downloaded using the instructions above. For additional instructions on completing and submitting the electronic application package, click on the “Show Instructions” tab that is accessible within the application package itself. 

    The application package consists of the following mandatory documents. 

    1. Application for Federal Assistance (SF 424):  Complete the form except for the “competition ID” field.

    2. EPA Key Contacts Form 5700-54:  Complete the form.  If additional pages are needed, see (d) below.

    3. SF-424A Budget Information for Non-Construction Programs: Only complete “Section B-Budget Categories”.   Provide the object class budget category (a. - k.) amounts for each budget year under the “Grant Program, Function or Activity” heading.  Each column reflects a separate budget year.

    4. Project Narrative Attachment Form (click on “Add Mandatory Project Narrative”):  Attach a single electronic PDF file labeled “Application” that contains the items described in Section IV.B.3. through IV.B.9.a (Table of Contents, Abstract, Research Plan, Quality Assurance Statement, Human Subjects Research Statement, Data Plan, Early Career Verification (for early career awards), References, Budget Justification, Resumes, Current and Pending Support, and Letters of Intent/Support) of this solicitation.  In order to maintain format integrity, this file must be submitted in Adobe Acrobat PDF.  Please review the PDF file for conversion errors prior to including it in the electronic application package; requests to rectify conversion errors will not be accepted if made after the solicitation closing date and time. If Key Contacts Continuation pages (see Forms and Standard Instructions Download Page) are needed, place them before the Table of Contents (Section IV.B.3.). 

      Please note that applicants are limited to using the following characters in all attachment file names.  Valid file names may only include the following UTF-8 characters: 
      A-Z, a-z, 0-9, underscore ( _ ), hyphen (-), space, period. If applicants use any other characters when naming their attachment files their applications will be rejected by grants.gov.

      Once the application package has been completed, the “Submit” button should be enabled.  If the “Submit” button is not active, please call Grants.gov for assistance at 1-800-518-4726.  Applicants who are outside the U.S. at the time of submittal and are not able to access the toll-free number may reach a Grants.gov representative by calling 606-545-5035.  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 ensure that your application is submitted to Grants.gov BEFORE 11:59:59 pm Eastern Time on the solicitation closing date.  The Grants.gov support desk operates 24 hours a day, seven days a week, except Federal Holidays.

    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. 

    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 following the above instructions do not resolve the problem so that the application is submitted to Grants.Gov by the deadline date and time, follow the guidance below.  The Agency will make a decision concerning each late submission on a case-by-case basis as to whether it should be forwarded for peer review.  All emails, as described below, are to be sent to peterson.todd@epa.gov with the FON in the subject line.

    Please note that if the application you are submitting is greater than 70 MB in size, please call or send an email message to the Electronic Submissions Contact listed for this RFA.  The Agency may experience technical difficulty downloading files of this size from Grants.gov.  Therefore, it is important that the Agency verify that the file can be downloaded.  The Agency will provide alternate submission instructions if the file cannot be downloaded.

    1. If you are experiencing problems resulting in an inability to upload the application to Grants.gov, it is essential to call Grants.gov for assistance at 1-800-518-4726 before the application deadline.  Applicants who are outside the U.S. at the time of submittal and are not able to access the toll-free number may reach a Grants.gov representative by calling 606-545-5035.  Be sure to obtain a case number from Grants.gov.
    2. Unsuccessful transfer of the 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 email message by 11:59:59 pm Eastern Time on the solicitation closing date. The email message must document the problem and include the Grants.gov case number as well as the entire application in PDF format as an attachment.
    3. Grants.gov rejection of the application package:  If a notification is received from Grants.gov stating that the application has been rejected for reasons other than late submittal, promptly send an email to Todd Peterson (peterson.todd@epa.gov) with the FON in the subject line within one business day of the closing date of this solicitation.  The email should include any materials provided by Grants.gov and attach the entire application in PDF format.

V. APPLICATION REVIEW INFORMATION

A. Peer Review
All eligible grant applications are reviewed by appropriate external technical peer reviewers   based on the criteria and process described below.  This review is designed to evaluate each application according to its scientific merit.  The individual external peer reviewers include 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.

Prior to the external technical peer review panel meeting, all reviewers will receive electronic copies of all applications, as well as a full set of abstracts for the applications. Each application will be assigned to a minimum of three primary peer reviewers, one of whom will be assigned the role of Rapporteur. Each reviewer will be assigned up to approximately 10 applications on which to serve as a primary reviewer. During the review period leading up to the panel meeting, primary reviewers will read the full set of abstracts and entire application package for each application they are assigned. They will also prepare a written individual evaluation for each assigned application that addresses the peer review criteria described below and rate the application with a score of excellent, very good, good, fair, or poor. 

At the beginning of the panel meeting, each primary reviewer will report their ratings for the applications they reviewed.  Those applications receiving at least two ratings of Very Good or one rating of Excellent from among the primary reviewers will then be further discussed by the panel in terms of the peer review criteria below.  In addition, if there is one Very Good rating among the primary reviewers of an application, the primary reviewer, whose initial rating is the Very Good, may request discussion of the application by the peer review panel.  All other applications will be declined for further consideration.

After the discussion of an application by the panel, the primary reviewers may revise their initial ratings and if they do so, this will also be documented. The final ratings of the primary reviewers will then be translated by EPA into the final peer review score (excellent, very good, good, fair, or poor) for the application. This is reflected in a peer review results document developed by the Rapporteur which combines the individual initial and final evaluations of the primary reviewers and captures any substantive comments from the panel discussion. This score will be used to determine which applications undergo the internal programmatic review discussed below.  A peer review results document is also developed for applications that are not discussed.  However, this document is a consolidation of the individual primary reviewer initial evaluations, with an average of the scores assigned by the primary reviewers.  

Peer reviewers consider an application’s merit based on the criteria below.  Criteria 1-6 are listed in descending order of importance:

  1. Research Proposal (criteria “1a” through “1h” are equal):
    1. The originality and creativity of the proposed research, the appropriateness and adequacy of the proposed research methods, and the Quality Assurance Statement.
    2. Practical and technically defensible approach that can be performed within the proposed time period.
    3. Research contributes to scientific knowledge in the topic area.
    4. The proposed research challenges and seeks to shift current research or engineering paradigms by using innovative theoretical concepts, approaches or methodologies, instrumentation or interventions applicable to one or more fields of research.
    5. Projected benefits of the proposed activity to society, such as improving the environment or human health.
    6. The proposed research embodies the principles of sustainability and seeks sustainable solutions that protect the environment and strengthen our communities.  The sustainability primer provides examples of research activities that promote and incorporate sustainability principles.
    7. The results are disseminated broadly to enhance scientific and technological understanding.
    8. The proposal is well prepared with supportive information that is self-explanatory or understandable.
  2. Investigators: The qualifications of the Principal Investigator(s) and other key personnel, including research training, demonstrated knowledge of pertinent literature, experience, and publication records.  All key personnel must make a significant time commitment to the project.
  3. Responsiveness: The responsiveness of the proposal to the research needs identified for the research area.  The proposal adequately addresses the objectives and special considerations specified by the RFA.
  4. Project management: The approach for ensuring successful achievement of project objectives is adequate and in accordance with the proposal's project schedule and milestones. The proposal adequately describes monitoring and measuring of progress toward achieving   expected results (outputs and outcomes).  The approach, procedures, and controls for ensuring timely and efficient expenditure of awarded grant funds are well defined and acceptable.
  5. Facilities and equipment: The availability and/or adequacy of the facilities and equipment proposed for the project.  Note any deficiencies that may interfere with the successful completion of the research.
  6. 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 final peer review scores of excellent or very good 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.

Those applicants who received final 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 PI’s (in the case of Multiple-PI applications, the Contact PI’s) "Past Performance and Reporting History."  The applicant must provide the EPA Project Officer with information on the proposed Lead/Contact PI's past performance and reporting history under prior Federal agency assistance agreements (assistance agreements include grants and cooperative agreements but not contracts) in terms of: (i) the level of success in managing and completing each agreement, and (ii) history of meeting the reporting requirements under each agreement.

This information is required only for the proposed Lead/Contact PI's performance under Federal assistance agreements initiated within the last three years that were similar in size and scope to the proposed project. 

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

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

The purpose of the programmatic review is to ensure 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 (relevance is more important than the Lead/Contact PI's past performance):

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

C. Human Subjects Research Statement (HSRS) Review
Applications being considered for funding after the Programmatic Review that involve human subjects research studies will have their HSRS reviewed by EPA’s HSRRO prior to award.  The HSRRO will review the information provided in the HSRS and the Research Plan to determine if the ethical treatment of human subjects is described in a manner appropriate for conditional approval to be granted. 

D. Funding Decisions
Final funding decisions are made by the NCER Director based on the results of the peer review and the internal programmatic review and, where applicable, the EPA HSRRO’s assessment of the applicant’s HSRS (see Section IV.B.5.c). In addition, in making the final funding decisions, the NCER Director may also consider program balance and available funds.  Applicants selected for funding will be required to provide additional information listed below under “Award Notices.” The application will then be forwarded to EPA’s Grants and Interagency Agreement Management Division for award in accordance with the EPA’s procedures.

VI. AWARD ADMINISTRATION INFORMATION

A. Award Notices
Customarily, applicants are notified about evaluation decisions within six months of the solicitation closing date.  A Peer Review Results document summarizing the scientific review  will be provided to each applicant with an award or declination letter. 

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

The official notification of an award will be made by the Agency’s Grants and Interagency Agreement Management Division.  Applicants are cautioned that only a grants officer is authorized to bind the Government to the expenditure of funds; preliminary selection by the NCER Director in the Office of Research and Development does not guarantee an award will be made.  For example, statutory authorization, funding, or other issues discovered during the award process may affect the ability of EPA to make an award to an applicant.  The award notice, signed by an EPA grants officer, is the authorizing document and will be provided through electronic or postal mail.

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 Dispute Resolution Procedures.  Questions regarding disputes may be referred to the Eligibility Contact identified below.

C. Administrative and National Policy Requirements
Additional provisions that apply to this solicitation and/or awards made under this solicitation, including but not limited to those related to DUNS, SAM, copyrights, disputes, and administrative capability, can be found at EPA Solicitation Clauses

These, and the other provisions that can be found at the website link, are important, and applicants must review them when preparing applications for this solicitation.  If you are unable to access these provisions electronically at the website above, please communicate with the EPA contact listed in this solicitation to obtain the provisions.

Expectations and responsibilities of NCER grantees and cooperative agreement holders are summarized in this section, although the terms grant and grantee are used.  See Guidance & Frequent Questions 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 of changes may be required from EPA. Examples of these changes are contained in 40 C.F.R. 30.25.  Note: prior written approval is also required from the EPA Award Official for incurring costs more than 90 calendar days prior to award.

  3. Human Subjects: A grant applicant must agree to meet all EPA requirements for studies using human subjects prior to implementing any work with these subjects.  These requirements are given in 40 CFR Part 26.  Studies involving intentional exposure of human subjects who are children or pregnant or nursing women are prohibited by Subpart B of 40 CFR Part 26.  For observational studies involving children or pregnant women and fetuses please refer to Subparts C & D of 40 CFR Part 26.  U.S. Department of Health and Human Services regulations at 45 CFR Part 46.101(e) have long required "... compliance with pertinent Federal laws or regulations which provide additional protection for human subjects."  EPA’s regulation 40 CFR 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 Part 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. 

    Guidance and training for investigators conducting EPA-funded research involving human subjects may be obtained here:
    Ethics, Regulations, and Policies
    Human Subjects Research at the Environmental Protection Agency: Ethical Standards and Regulatory Requirements

  4. Data Access and Information Release: After award, all data first produced under the award 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 EPA Information Quality Guidelines (EPA IQG).  These procedures may apply to data generated by grant recipients if those data are disseminated as described in the Guidelines.

  5. 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 NCER 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.

  6. 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 Assistance Agreement No.________ awarded by the U.S. Environmental Protection Agency to [name of recipient].  It has not been formally reviewed by EPA.  The views expressed in this document are solely those of [name of recipient or names of authors] and do not necessarily reflect those of the Agency.  EPA does not endorse any products or commercial services mentioned in this publication.

VII. AGENCY CONTACTS

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

Technical Contact: Jayne Michaud (michaud.jayne@epa.gov); phone: 703-305-1968
Electronic Submissions: Todd Peterson (peterson.todd@epa.gov); phone: 703-308-7224
Eligibility Contact: Ron Josephson (josephson.ron@epa.gov); phone: 703-308-0442

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