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

CLOSED - FOR REFERENCES PURPOSES ONLY

Exploratory Research: Nanotechnology Research Grants Investigating Environmental and Human Health Effects of Manufactured Nanomaterials: a Joint Research Solicitation-EPA, NSF, NIOSH, NIEHS

This is the initial announcement of this funding opportunity.

Funding Opportunity Numbers:

Catalog of Federal Domestic Assistance (CFDA) Number: EPA: 66.509; NIOSH: 93.262; NIEHS: 93.114; NSF: 47.041

Solicitation Opening Date: December 20, 2005
Solicitation Closing Date: February 22, 2006, 4:00 pm Eastern Time

Eligibility Contact: Tom Barnwell: 202-343-9862; email: barnwell.thomas@epa.gov
Electronic Submissions: Bronda Harrison, PhD; 202-343-9777; email: harrison.bronda@epa.gov
Technical Contacts:

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

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

SUMMARY OF PROGRAM REQUIREMENTS

Synopsis of Program
The U.S. Environmental Protection Agency (EPA), Office of Research and Development (ORD) as part of its Science to Achieve Results (STAR) program; the National Science Foundation (NSF), Engineering Directorate; the National Institute for Occupational Safety and Health, (NIOSH), Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS) ; and the National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH), Department of Health and Human Services (DHHS), are seeking applications proposing research about the potential implications of nanotechnology and manufactured nanomaterials on human health and the environment. Research areas can include the toxicology, fate, transport and transformation, bioavailability, exposures of human and other species in natural ecosystems to nanomaterials, and industrial ecology related to nanomaterials.

This is the initial announcement of this funding opportunity. Although not anticipated, should modifications of this announcement be necessary, they will be posted appropriately.

Award Information:
Anticipated Type of Award: Grant

Estimated Number of Awards: Approximately 25 awards

Anticipated Funding Amount: Approximately $8 million total costs for all awards under this announcement depending on availability of funds in fiscal year 2006. EPA intends to commit up to $5,000,000 and NIOSH, NSF, and NIEHS intend to commit up to $1,000,000 each depending on availability of funds in fiscal year 2006.

Potential Funding per Grant: For a grant proposing research on: toxicological and biological effects of manufactured nanomaterials; environmental and biological fate, transport, and transformation of manufactured nanomaterials; or exposure/bioavailability of humans and other species to manufactured nanomaterials, an applicant may request a project period of up to three years and a budget for total costs (direct and indirect) not to exceed $400,000. For an exploratory research grant under the above referenced topic areas or for life cycle assessment, an applicant may request a project period for up to two years and a budget for total costs (direct and indirect) not to exceed $200,000. Although the financial plans of EPA, NIOSH, NSF and NIEHS currently provide support for this funding opportunity, awards pursuant to this request for applications (RFA) are contingent upon the availability of funds and the receipt of a sufficient number of meritorious applications. Proposals with budgets exceeding the total award limits will not be considered.

Eligibility Information:
EPA will fund institutions of higher education and not-for-profit institutions located in the U.S., and tribal, state and local governments. Universities and educational institutions must be subject to OMB Circular A-21. Profit-making firms are not eligible to receive grants from the EPA under this funding opportunity.

NSF, NIOSH, and NIEHS will fund the following: for-profit or nonprofit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of state and local governments; eligible agencies of the Federal government; domestic institutions/organizations only; faith-based community-based organizations; federally recognized Indian Tribes, Tribal Governments, Colleges, and/or Organizations. See full announcement for more details.

Note: An organization described in section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant or loan.

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

Contact Persons:
Eligibility Contact: Tom Barnwell; phone: 202-343-9862; email: barnwell.thomas@epa.gov
Electronic Submissions Contact: Bronda Harrison; phone: 202-343-9777; email: harrison.bronda@epa.gov
Technical Contacts:
Nora Savage, PhD; Environmental Protection Agency; Telephone: 202-343-9858; Email: savage.nora@epa.gov
Cynthia J. Ekstein, PhD; National Science Foundation; Telephone: 703-292-7941; Email: cekstein@nsf.gov
Adele M. Childress, PhD, M.S.P.H.; Office of Extramural Programs; National Institute for Occupational Safety and Health; Centers for Disease Control and Prevention; Telephone: 404-498-2509; Email: ahc0@cdc.gov
Sally S. Tinkle, PhD, National Institute of Environmental Health Sciences; Telephone: 919-541-5327; Email: tinkle@niehs.nih.gov

I. FUNDING OPPORTUNITY DESCRIPTION

Introduction
The purpose of this collaborative research program is to strengthen the Environmental Protection Agency’s (EPA), the National Science Foundation’s (NSF), Engineering Directorate, the National Institute for Occupational Safety and Health’s, (NIOSH), Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS), and the National Institute of Environmental Health Sciences’ (NIEHS), National Institutes of Health (NIH), Department of Health and Human Services (DHHS) support of research on the potential implications of nanotechnology and manufactured nanomaterials on human health, workplace safety, and the environment. The RFA sponsors are particularly interested in supporting research related to manufactured nanomaterials in the any of following areas: (1) toxicological and biological effects of manufactured nanomaterials; (2) environmental and biological fate, transport, and transformation of manufactured nanomaterials; (3) human exposure/bioavailability; and (4) life cycle assessment.

EPA supports research to meet its mission of protecting human health and the environment. Research solicited under this funding announcement will be used by the engineering and scientific community in risk assessment, specifically in hazard identification and exposure assessment. EPA is interested in funding research on the possible risks and exposure routes of newly produced chemicals and materials at the nanoscale. Information regarding current research can be found on ORD's National Center for Environmental Research (NCER) web site at www.epa.gov/ncer/nano.

NSF supports research to help meet its mission, i.e., “to promote the progress of science; to advance the national health, prosperity, and welfare; and to secure the national defense.” Information resulting from this solicitation will be used to assist and enable the engineering and scientific communities to advance the frontiers of research, innovation, and education. The research should focus on emerging and potentially transformative ideas, and application of new expertise or new approaches to “established” topics.

NIOSH supports research to meet its mission, i.e ., “ to provide leadership in preventing work-related illnesses and injuries.” Information resulting from this solicitation will be used to identify and investigate the relationships between hazardous working conditions and associated occupational diseases and injuries; to develop more sensitive means of evaluating hazards at work sites, as well as methods for measuring early markers of adverse health effects and injuries; to develop new protective equipment, engineering control technology, and work practices to reduce the risks of occupational hazards; and to evaluate the technical feasibility or application of a new or improved occupational safety and health procedure, method, technique, or system.

NIEHS supports research to meet its mission to reduce the burden of human illness and dysfunction from environmental causes by defining how environmental exposures affect an individual's health status. Information resulting from this solicitation will be used to determine the characteristics of nanomaterial biocompatibility and toxicity and will contribute to exposure assessment and risk evaluation. NIEHS is interested in funding research that explores dose metrics and routes of nanomaterial exposure, and the molecular, cellular, and organ system response to exposure.

Background
Nanotechnology has been defined by the interagency Subcommittee on Nanoscale Science, Engineering and Technology (NSET) of the Federal Office of Science and Technology Policy (OSTP) as follows: “Research and technology development at the atomic, molecular or macromolecular levels, in the length scale of approximately 1 - 100 nanometer range, that provide a fundamental understanding of phenomena and materials at the nanoscale and to create and use structures, devices and systems that have novel properties and functions because of their small and/or intermediate size. The novel and differentiating properties and functions are developed at a critical length scale of matter typically under 100 nm. Nanotechnology research and development includes manipulation and control of the nanoscale structures and their integration into larger material components, systems and architectures.” (See http://www.nano.gov exit EPA for more information)

Many companies are currently involved in the manufacture of nanoscale materials which are used in a wide range of products, such as sunscreens, composites, medical devices, and chemical catalysts. According to data collected by the National Nanotechnology Initiative (NNI), the quantity of nanoscale materials manufactured by various industries is expected to grow significantly in the next five years. Business Communications Company has projected a $10 billion global demand for nanoscale materials, tools, and devices in 2010. This large increase in demand and production could lead to unintended exposures of nanoscale materials to humans and other organisms.

There is insufficient information about the human health and environmental implications of manufactured nanomaterials, e.g., nanoparticles, nanotubes, nanowires, fullerene derivatives, and other nanoscale materials. Figure 1 provides an overview of nanostructures, their size, and material into which they may be formed. Environmental and other safety concerns about nanotechnology have been raised (Masciangoli and Zhang, 2003; Colvin, 2004). This solicitation requests research proposals which address potential health and environmental concerns of nanomaterials using the best science available to support EPA's mission to protect human health and the environment, NSF’s mission to promote the progress of science and national welfare, NIOSH’s mission to help assure safe working conditions, and NIEHS’s mission to understand the human health consequence of environmental exposures.

Characterization parameters of nanoparticulate materials (Adapted
  from Wolfgang Luther, ed., “Industrial Applications of Nanomaterials:
  Chances and Risks – Technological Analysis,” Futures Technologies
  Division of VDI Technologiezentrum GmbH, Dusseldorf, Germany, 2004, 43.)

Figure 1: Characterization parameters of nanoparticulate materials (Adapted from Wolfgang Luther, ed., “Industrial Applications of Nanomaterials: Chances and Risks – Technological Analysis,” Futures Technologies Division of VDI Technologiezentrum GmbH, Dusseldorf, Germany, 2004, 43.)

In the case of nanomaterials, size matters; the small size might facilitate or exacerbate any harmful effects caused by the component material. Potentially harmful effects might arise as a result of the properties of the nanomaterials themselves or the products made from them, as well as through the manufacturing process involved. The increased surface area, unique crystalline structure, small size, and enhanced reactivity of some nanomaterials dictate transport properties within the environment and may lead to harmful interactions with cellular material.

Little is known about the fate, transport, and transformation of nanosized materials after they enter the environment. As the production of manufactured nanomaterials increases and as products containing manufactured nanomaterials are produced, used, recycled, or disposed of, these materials could have harmful effects on the ecosystem. It is unknown to what extent nanomaterials bioaccumulate or pose further risks to human health and the environment through biomagnification along the food chain.

Some research has been done on inhalation and dermal exposure to nanoparticles (Oberdorster, 2005). This research may inform the manufactured nanomaterials area. However, much of the current research addresses exposures to ultrafine particles (defined at those particles with sizes ranging from 1-100nm). This research on “incidental” nanoparticles may not be applicable to manufactured nanoparticles because the ultrafine/incidental materials studied possess neither consistency in size and shape nor purity in chemical and structural composition. Studies of ingestion routes of exposure to nanomaterials have been neglected for both incidental and manufactured nanomaterials.

The primary EPA Strategic Goal, Objective and Sub-objective that relates to this solicitation is: Goal 4: Healthy Communities and Ecosystems, Objective 4.5: Enhance Science and Research, Sub-objective 4.5.2 Conduct Relevant Research. This solicitation also supports Goal 5: Compliance and Environmental Stewardship, Objective: 5.4 Enhance Science and Research, Sub-objective 5.4.2 Conducting Research. The Cross-Goal Strategies in Partnerships and in Science also relate to this solicitation. EPA’s Strategic Plan can be found on the following web page: http://www.epa.gov/ocfo/plan/2003sp.pdf.

Authorities and Regulations
EPA’s authority for this RFA and resulting awards is contained in the Safe Drinking Water Act, Section 1442, 42 U.S.C. 300j-1; the Clean Water Act, Section 104, 33 U.S.C.; the Toxic Substances Control Act, Section 10, 15 U.S.C. 2609; the Clean Air Act, Section 103, 42 U.S.C. 7403; and the Solid Waste Disposal Act, Section 8001, 42 U.S.C. 6901.

NIOSH awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284), the Occupational Safety and Health Act of 1970, Section 20(a)[29 USC 669(a)], and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All NIOSH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

NIEHS awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR 52 and 45 CFR Parts 74 and 92. All NIEHS awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Specific Research Areas of Interest/Expected Outputs and Outcomes
The RFA sponsors are particularly interested in supporting research related to manufactured nanomaterials in the any of following areas: (1) toxicological and biological effects of manufactured nanomaterials; (2) environmental and biological fate, transport, and transformation of manufactured nanomaterials; (3) exposure/bioavailability of humans and other species to manufactured nanomaterials; and (4) life cycle assessment. The RFA sponsors are also soliciting exploratory research related to topic areas 1-3 listed above.

  1. Toxicological and biological effects of manufactured nanomaterials
  2. Manufactured nanomaterials or nanocomposites may be toxic to humans and other species in natural ecosystems because of their composition, unique size, or structural properties. Relevant research questions might include, but are not limited to: What is the toxicity or potential toxicity of manufactured nanomaterials? Can similar nanomaterials be grouped with respect to their bioactivity? What are the health effects associated with nanomaterial-mixed exposures or multiple exposure routes? What are the dose-response characteristics of nanomaterials? What are appropriate testing procedures, models, and biomarkers to evaluate the potential toxicological effects of nanomaterials in humans and/or other species in natural ecosystems? What extrapolation models are needed to evaluate or predict toxicity? What is the mode of action and mechanism of toxicity? What effects may occur in exposed human and wildlife populations? Are some subpopulations more sensitive to nanomaterials? Do nanoparticles impact ecological (animal/plant) receptors? Relevant results of this research would include increased scientific knowledge of the mechanisms by which these materials impart toxicity, enhanced knowledge of the important dose/response characteristics, and data on likely human health effects. Outputs/outcomes would include improved protection of public health through an enhanced understanding of the toxicology of engineered nanomaterials, an improved understanding of how to lessen or modify the toxicity of these materials, and an increased scientific knowledge on the potential adverse health effects of these materials.

  3. Environmental and biological fate, transport, and transformation of manufactured nanomaterials
  4. Information about fate, transport, and transformation is necessary to estimate exposure to manufactured nanomaterials. Relevant research questions might include, but are not limited to: By what means do (can) manufactured nanomaterials enter the environment? What forms of nanomaterials are bioavailable? What are the modes of dispersion/aggregation for nanomaterials in the environment? Do manufactured nanoparticles undergo transformation in the environment? Are more toxic metabolites formed in biological systems? Do manufactured nanoparticles bioaccumulate through the food chain? How are nanomaterials translocated from one organ to another? How do nanomaterials transfer from one media to another? Relevant results of this research would include providing scientific knowledge on the partitioning of nanomaterials in various media and increased data on movement and transformation capacities. Outputs/outcomes would include providing researchers with critical information concerning the fate of manufactured nanomaterials, progress review workshops geared towards increasing the collaboration and coordination of environmental research on manufactured nanomaterials, and improved environmental protection through the knowledge gained concerning the fate, transport, and transformation of engineered nanomaterials as they enter and move through various ecosystems.

  5. Exposure/Bioavailability of humans and other species to manufactured nanomaterials
  6. There may be risks to human health associated with manufactured nanomaterials. However, if there is no exposure, there are no health risks. With respect to exposure, relevant research questions might include, but are not limited to: How and to what degree are humans exposed to nanomaterials in the environment and workplace? What effects may occur in exposed human populations and occupations? Are some subpopulations more vulnerable to nanomaterial exposure? What are the exposure pathways for humans? What are the effects of nanomaterials and mixtures on current engineering controls and personnel protective equipment? What releases might occur from the manufacturing processes of nanomaterials? How can exposures be quantified? At what stages in the product lifecycle might exposure occur? Relevant results of this research would include gaining insight into the type, extent and timing of exposure. In addition, the scientific community will gain increased knowledge into the exposure patterns of nanomaterials. Outputs/outcomes would include improved protection of the environment and human health through the understanding of exposure to manufactured nanomaterials, an increase in scientific data on exposure of living systems and the environment to engineered nanomaterials, an increase in information concerning where and when potential outcomes may occur for specific manufactured nanomaterials, and progress review workshops and other workshops geared towards increasing the collaboration and coordination of environmental research on manufactured nanomaterials.

  7. Life cycle assessment (LCA)
  8. LCA is a technique to assess the environmental aspects and potential impacts associated with a product, process, or service, by compiling an inventory of relevant energy and material inputs and environmental releases through a full life cycle from extraction through production, product and end of life; evaluating the potential environmental impacts associated with identified inputs and releases; and interpreting the results to help make a more informed decision. Relevant research questions might include, but are not limited to: Can the tools of LCA be developed and used proactively to determine environmental impacts of nanomaterials and products? How can substance flow analysis inform environmental impacts? Can life cycle tools help in decision making to minimize the environmental impact of nanomaterials and products? How will changes from current processes to nanotechnology processes affect material flows of hazardous substances? What are the lifecycle impacts from the manufacturing processes for nanomaterials? Relevant results of this research would include a better understanding of the life cycle of manufactured nanomaterials, from starting material to the end of life of the product. Outputs/outcomes include an improved database for the various life cycle stages of manufactured nanomaterials, the collection of critical data required for accurate and complete life cycle assessments to be performed, progress review workshops geared towards increasing the collaboration and coordination of environmental research on manufactured nanomaterials, providing the scientific community and policy makers with a tool that will enable prediction of the most likely impact of these materials, and an improved understanding of where the impact of a particular manufactured nanomaterial is most likely to occur would be greatly improved.

  9. Exploratory - Toxicological and biological effects of manufactured nanomaterials
  10. Manufactured nanomaterials or nanocomposites may be toxic to humans and other species in natural ecosystems because of their composition, unique size, or structural properties. Research that is exploratory in nature which investigates potential toxicity issues, mechanisms and strategies are requested. Outputs/outcomes would include improved protection of public health through an enhanced understanding of the toxicology of engineered nanomaterials, an improved understanding of how to lessen or modify the toxicity of these materials, and an increased scientific knowledge on the potential adverse health effects of these materials. Proposals in this category are for a maximum 2-year project period and budgeted at $200,000 or less.

  11. Exploratory - Environmental and biological fate, transport, and transformation of manufactured nanomaterials
  12. Information about fate, transport, and transformation is necessary to estimate exposure to manufactured nanomaterials. Research that is exploratory in nature which investigates how these materials might behave in environmental or biological settings including methods of entry, ultimate fate and movement or translocation issues are requested. Outputs/outcomes would include providing researchers with critical information concerning the fate of manufactured nanomaterials, progress review workshops geared towards increasing the collaboration and coordination of environmental research on manufactured nanomaterials, and improved environmental protection through the knowledge gained concerning the fate, transport, and transformation of engineered nanomaterials as they enter and move through various ecosystems.

    Proposals in this category are for a maximum 2-year project period and budgeted at $200,000 or less.

  13. Exploratory - Exposure/Bioavailability of humans and other species to manufactured nanomaterials
  14. There may be risks to human health associated with manufactured nanomaterials. However, if there is no exposure, there are no health risks. Research that is exploratory in nature which investigates potential exposure of living organisms or the environment and the accessibility of these systems to manufactured nanomaterials are requested. Outputs/outcomes would include improved protection of the environment and human health through the understanding of exposure to manufactured nanomaterials, an increase in scientific data on exposure of living systems and the environment to engineered nanomaterials, an increase in information concerning where and when potential outcomes may occur for specific manufactured nanomaterials, and progress review workshops and other workshops geared towards increasing the collaboration and coordination of environmental research on manufactured nanomaterials. Proposals in this category are for a maximum 2-year project period and budgeted at $200,000 or less.

References

Colvin, V. 2003. The potential environmental impact of engineered nanomaterials Nature Biotechnology 21, 1166 – 1170.

Jortner, J and CNR Rao. 2002. ‘Nanostructured Advanced Materials. Perspectives and Directions’ Pure Appl. Chem. 74(9), 1491-1506.

Masciangioli, TM and W-X Zhang. 2003. ‘Environmental Technologies at The Nanoscale: Potential & Pitfalls.’ Environ. Sci. Tech. 37 (5):102A – 108A.

Oberdörster G, Oberdörster E, Oberdörster J. 2005. ‘NANOTOXICOLOGY: An Emerging Discipline Evolving from Studies of Ultrafine Particles.’ Environ. Health Perspect. doi:10.1289/ehp.7339. [Online 22 March 2005]

The Royal Society and the Royal Academy of Engineering, Nanoscience and nanotechnologies: Opportunities and uncertainties, London, July 2004, pp. 26-7, available online at www.nanotec.org.uk/finalReport.htm.

Special Requirements
Because the manufacturing of nanomaterials is not currently widespread and nomenclature is not standard, researchers must indicate in their proposals which nanomaterials they will use and where they will obtain them, including any needed collaboration with a materials manufacturing corporation or research lab that is synthesizing a commercially viable material. Thus, in the proposal, information on the source, potential use, composition, and present or future availability of the material being studied must be included, as well as a biohazards handling plan. Researchers are encouraged to explore the appropriateness and availability of special nanotechnology user facilities at the Department of Energy (http://www.nano.gov/html/centers/DOEcenters.html exit EPA), the National Institute of Standards and Technology (http://www.nano.gov/html/centers/NISTcenters.html exit EPA), and the NSF, under the National Nanotechnology Infrastructure Network program (http://www.nnin.org/ exit EPA).

EPA policy prevents EPA scientists and engineers from providing individual applicants with information that would provide them with an unfair competitive advantage. Consequently, EPA scientists and engineers will not review, comment, advise, or provide technical assistance to applicants preparing applications in response to EPA RFAs, or discuss in any manner how the Agency will apply the published evaluation criteria for this competition.

II. AWARD INFORMATION

It is anticipated that a total of approximately $8 million will be awarded under this announcement, depending on the availability of funds. The EPA, NIOSH, NSF, and NIEHS anticipate funding approximately 25 total grants under this RFA.

Table of Funding Categories

Topic Area

Funding Opportunity Number

*Max Annual Costs

Max # Years

*Max Total Costs

Toxicology

EPA-G2006-STAR-F1

$133,000

3

$400,000

Fate/Transport

EPA-G2006-STAR-F2

$133,000

3

$400,000

Exposure/Bioavailability

EPA-G2006-STAR-F3

$133,000

3

$400,000

Life Cycle Assessment

EPA-G2006-STAR-F4

$100,000

2

$200,000

Exploratory Toxicology

EPA-G2006-STAR-F5

$100,000

2

$200,000

Exploratory Fate/Transport

EPA-G2006-STAR-F6

$100,000

2

$200,000

Exploratory Exposure/Bioavailability

EPA-G2006-STAR-F7

$100,000

2

$200,000

*Includes direct and indirect costs.

Requests in excess of the amounts above will not be considered. The total project period for an application submitted in response to this RFA may not exceed the maximum years shown above.

Awards are contingent upon availability of funds and receipt of a sufficient number of meritorious applications. The EPA reserves the right to reject all applications and make no awards under this RFA. The EPA reserves the right to make additional awards under this RFA if additional funding becomes available. Any additional selections for awards will be made no later than 4 months after the original selection decisions.

EPA intends to fund grants rather than cooperative agreements under this announcement. Agency scientists and engineers will not be substantially involved in grants receiving EPA funding. However, EPA encourages interaction between its own laboratory scientists and grant Principal Investigators after the award of an EPA grant for the sole purpose of exchanging information in research areas of common interest that may add value to their respective research activities. This interaction must be incidental to achieving the goals of the research under a grant. Interaction that is "incidental" does not involve resource commitments.

III. ELIGIBILITY INFORMATION

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

NSF,NIOSH, and NIEHSwill fund the following: for-profit or nonprofit organizations; public or private institutions, such as universities, colleges, hospitals, and laboratories; units of state and local governments; eligible agencies of the Federal government; domestic institutions/organizations only; faith-based community-based organizations; federally recognized Indian Tribes, Tribal Governments, Colleges, and/or Organizations.

Note: An organization described in section 501(c)(4) of the Internal Revenue Code that engages in lobbying activities is not eligible to receive Federal funds constituting an award, grant or loan.

National laboratories funded by Federal Agencies Federally-Funded Research and Development Centers (FFRDCs) are not eligible for EPA funding. 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 grant 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 are not eligible for EPA funding. Federal employees are not eligible to serve in a principal leadership role on a grant, and may not receive salaries or augment their Agency's appropriations in other ways through grants made by EPA. The applicant institution may enter into an agreement with a Federal Agency to purchase or utilize unique supplies or services unavailable in the private sector. Examples are purchase of satellite data, census data tapes, chemical reference standards, analyses, or use of instrumentation or other facilities not available elsewhere. A written justification for federal involvement must be included in the application. In addition, an appropriate form of assurance that documents the commitment, such as a letter of intent from the Federal Agency involved, should be included.

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

Cost-Sharing
Institutional cost-sharing is not required.

Other
Applications that do not substantially comply with the application submission instructions and requirements set forth in Section IV of this announcement will be rejected. In addition, where a page limit is expressed in Section IV with respect to parts of the application, pages in excess of the page limitation will not be reviewed. Applications must be received by the EPA on or before the solicitation closing date published in Section IV of this announcement. Applications received after the published closing date will be returned to the sender without further consideration. Also, applications exceeding the funding limits described herein will be returned without review. In addition, applications that fail to demonstrate a public purpose of support or stimulation will not be funded.

IV. APPLICATION AND SUBMISSION INFORMATION

You may submit either a paper application or an electronic application (but not both) for this announcement. Instructions for both forms of submission follow.

Internet Address to Request Application Package
For paper applications, forms and instructions can be found on the NCER web site: http://www.epa.gov/ncer/rfa/forms/.

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

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

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

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

    Applicants are required to provide a “Dun and Bradstreet Data Universal Numbering System” (DUNS) number in Item 5 when applying for federal grants or cooperative agreements. Organizations may receive a DUNS number by calling 1-866-705-5711 or by visiting the web site at http://www.dnb.com exit EPA.

    Executive Order 12372, “Intergovernmental Review of Federal Programs,” applies to most EPA programs and assistance agreements, unless the program or assistance agreement supports tribal, training/fellowships (other than Wastewater and Small Water Systems Operator training programs), and research and development (with some exceptions). Item 16 of the SF424 refers to this requirement. Selection of research proposals is limited to those administered by EPA’s Office of Research and Development which: (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. Otherwise, national research programs are exempt from review. Applicants should consult http://www.whitehouse.gov/omb/grants/spoc.html exit EPA to determine whether their state participates in this process and how to comply.

  3. Key Contacts
  4. The applicant must complete the “Key Contacts” form as the second page of the application; the Key Contacts continuation page is also available http://www.epa.gov/ncer/rfa/forms. The Key Contacts form should also be completed for major sub-agreements (i.e., contacts at the institutions for primary co-investigators). Please make certain that all contact information is accurate.

  5. Table of Contents
  6. Provide a list of the major subdivisions of the application indicating the page number on which each section begins. (A Table of Contents is not required for electronic submissions.)

  7. Abstract (1 page)
  8. The abstract is a very important document in the review process. Therefore, it is critical that the abstract accurately describes the research being proposed and conveys all the essential elements of the research. Also, the abstracts of applications that receive funding will be posted on the NCER web site.

    The abstract should include the information indicated in the example format and described below (1-8). Examples of abstracts for current grants may be found on the NCER web site.

    1. Research Category and Funding Opportunity Number: The appropriate research areas and associated numbers for this RFA are:
      • Nanotechnology Research Grants Investigating Environmental And Human Health Effects of Manufactured Nanomaterials: A Joint Research Solicitation - EPA, NSF, NIOSH, NIEHS, Funding Opportunity Number:
        • EPA-G2006-STAR-F1 – Toxicology
        • EPA-G2006-STAR-F2 – Fate/Transport
        • EPA-G2006-STAR-F3 – Exposure/Bioavailability
        • EPA-G2006-STAR-F4 – Life Cycle Assessment
        • EPA-G2006-STAR-F5 – Exploratory Toxicology
        • EPA-G2006-STAR-F6 – Exploratory Fate/Transport
        • EPA-G2006-STAR-F7 – Exploratory Exposure/Bioavailability
    2. Title: Use the exact title of your project as it appears in the application. The title must be brief yet represent the major thrust of the project. Because the title will be used by those not familiar with the project, strike a balance between highly technical words and phrases and more commonly understood terminology. Do not use general phrases such as “research on”.
    3. Investigators: List the Principal Investigator, then the names and affiliations of each co-investigator who will significantly contribute to the project. Provide a web site URL or an email contact address for additional information.
    4. Institution: In the same order as the list of investigators, list the name, city and state of each participating university or other applicant institution. The institution applying for assistance must be clearly identified.
    5. Project Period: Show the proposed project beginning and ending dates.
    6. Project Cost: Show the total dollars requested from the EPA (include direct and indirect costs for all grant years).
    7. Project Summary: Provide three subsections addressing: (a) the objectives of the study (including any hypotheses that will be tested), (b) the experimental approach to be used (a description of the project proposed), and (c) the expected results of the project and how it addresses the research needs identified in the solicitation, including the estimated improvement in risk assessment or risk management that will result from successful completion of the proposed work.
    8. Supplemental Keywords: Without duplicating terms already used in the text of the abstract, list keywords to assist database searchers in finding your research. A list of suggested keywords can be found at: http://www.epa.gov/ncer/rfa/forms.

  9. Research Plan and Quality Assurance Statement
  10. 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.

    Because the manufacturing of nanomaterials is not currently widespread and nomenclature is not standard, researchers must indicate in their proposals which nanomaterials they will use and where they will obtain them, including any needed collaboration with a materials manufacturing corporation or research lab that is synthesizing a commercially viable material. Thus, in the proposal, information on the source, potential use, composition, and present or future availability of the material being studied must be included, as well as a biohazards handling plan. Researchers are encouraged to explore the appropriateness and availability of special nanotechnology user facilities at the Department of Energy (http://www.nano.gov/html/centers/DOEcenters.html exit EPA), the National Institute of Standards and Technology (http://www.nano.gov/html/centers/NISTcenters.html exit EPA), and the NSF, under the National Nanotechnology Infrastructure Network program (http://www.nnin.org/ exit EPA).

    The description must provide the following information:

    1. Objectives: List the objectives of the proposed research and the hypotheses being tested during the project, and briefly state why the intended research is important. This section should also include any background or introductory information that would help explain the objectives of the study. If this application is to continue research supported by an existing or former grant awarded under the STAR program, indicate the number of the grant and provide a brief report of progress and results achieved under that grant (one to two pages recommended).
    2. Approach/Activities: Outline the research design, methods, and techniques that you intend to use in meeting the objectives stated above (five to ten pages recommended).
    3. Expected Results, Benefits, Outputs, and Outcomes: Describe the results you expect to achieve during the project (outputs) and the 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 understand the merits of the research (one to two pages recommended).
    4. General Project Information: Discuss other information relevant to the potential success of the project. This should include facilities, personnel expertise/experience, project schedules, proposed management, interactions with other institutions, etc. Applications for multi-investigator projects must identify project management and the functions of each investigator in each team and describe plans to communicate and share data (one to two pages recommended).
    5. Important Attachments: References cited are in addition to the 15-page Research Plan limit. Appendices may be included but must remain within the 15-page limit.

    Quality Assurance Statement (2 pages in addition to the 15-page research plan)

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

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

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

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

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

  11. Budget and Budget Justification
  12. Budget

    Prepare a budget table using the guidance and format found at http://www.epa.gov/ncer/rfa/forms/, and select “All required forms”. If a sub-agreement, such as a subcontract, is greater than $25K and is included in the application, provide a separate budget for the sub-agreement. Include the total amount for the sub-agreement under “Contracts” in the master budget. Any project containing sub-agreements that constitute more than 40% of the total direct cost of the grant will be subject to special review. Additional justification for use of such subcontracts must be provided, discussing the need for this agreement to accomplish the objectives of the research project.

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

    Budget Justification (2 pages in addition to the Section E. page limitations)

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

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

    1. Personnel: List all staff positions by title. Give annual salary, percentage of time assigned to the project, and total cost for the budget period.
    2. Fringe Benefits: Identify the percentage used and the basis for its computation.
    3. Travel: Specify the estimated number of trips, locations, and other costs for each type of travel. Explain the need for any travel outside the United States. Include travel funds for annual STAR program progress reviews and a final workshop to report on results.
    4. Equipment: Identify all tangible, non-expendable personal property to be purchased that has an estimated cost of $5,000 or more per unit and a useful life of more than one year. (Personal property items with a unit cost of less than $5,000 are considered supplies.)
    5. Supplies: “Supplies” means tangible property other than “equipment”. Identify categories of supplies to be procured (e.g., laboratory supplies or office supplies) and specifically identify computers to be purchased or upgraded.
    6. Contractual: Identify each proposed sub-agreement (grant or contract) and specify its purpose and estimated cost. Sub-agreements more than $25K should have a separate itemized budget and budget justification, not to exceed one additional page each, included as part of the application.
    7. Other: List each item in sufficient detail for the EPA to determine the reasonableness of its cost relative to the research to be undertaken.
    8. Indirect Costs: If indirect costs are included in the budget, indicate the approved rate and base with an explanation of how indirect costs were calculated.

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

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

  15. Guidelines, Limitations, and Additional Requirements
  16. Confidentiality

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

    In accordance with 40 CFR 2.203, applicants may claim all or a portion of the application/proposal as confidential business information (for example, hypotheses or methodologies contained in the research narrative that the applicant wishes to protect from possible public disclosure). EPA will evaluate confidentiality claims in accordance with 40 CFR Part 2. Applicants must clearly mark applications/proposals or portions of applications/proposals they claim as confidential. If no claim of confidentiality is made, the EPA is not required to make an inquiry to the applicant otherwise required by 40 CFR 2.204(c)(2) prior to disclosure.

    Funding Opportunity Number

    At various places in the application, applicants are asked to identify the funding opportunity number. The number must be placed at the top of the abstract (location is shown in the abstract format, http://www.epa.gov/ncer/rfa/forms) and in Box 10 of Standard Form 424 for all applications. For paper submissions, the number must also be placed in the address on the package that is sent to the EPA (see below). Each application must be submitted using a single funding opportunity number. The funding opportunity numbers for applications submitted in response to this solicitation are:


    Applicants must select a funding opportunity number corresponding to their proposed research topic area in the solicitation. It is the responsibility of the applicant to identify the proper opportunity number based on the nature of the proposed research. Failure to do so could result in an inappropriate peer review assignment. If your research seems to fit under more than one funding opportunity number, choose the most appropriate one. For electronic submissions, you must use the appropriate electronic application package (see “Submission Instructions for Electronic Applications”) for the chosen funding opportunity number.

    Letters of Intent/Letters of Support

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

    Principal investigators may believe that letters of support from local constituencies contribute to the relevance of their proposal. All letters that do not commit a resource vital to success of the proposal are considered letters of support. Letters of intent that exceed one brief paragraph and letters of support are considered part of the Research Plan and included in the 15-page Research Plan limit.

Submission Dates and Times

For paper copy submissions, the original and two (2) copies of the complete application (3 in all), and one (1) additional copy of the abstract, must be received by NCER no later than 4:00 pm Eastern Time on the solicitation closing date. Electronic applications must be transferred to grants.gov no later than 4:00 pm Eastern Time on the solicitation closing date. It should be noted that this schedule may be changed without prior notification because of factors that were not anticipated at the time of announcement. In the case of a change in the required application closing date, a new date will be posted on the NCER web site (http://www.epa.gov/ncer/) and a modification posted on www.grants.gov exit EPA. Applications received after the closing date will be returned to the sender without further consideration.

Solicitation Closing Date Date: February 22, 2006, 4:00 pm Eastern Time
Earliest Anticipated Start Date: August 2006

Funding Restrictions
The funding mechanism for all awards issued under this solicitation will consist of assistance agreements from the EPA, NIOSH, NSF, or NIEHS. 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 a grant is to accomplish a public purpose of support or stimulation authorized by federal statute, rather than acquisition for the direct benefit or use of the Federal Government. In issuing a grant agreement, the EPA anticipates that there will be no substantial EPA involvement in the design, implementation, or conduct of the research. However, the EPA will monitor research progress through annual reports provided by grantees and other contacts, including site visits, with the Principal Investigator.

All NIOSH awards are subject to the NIH terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm exit EPA. Applications funded by NIOSH will use the modular budget format and funded applicants will be requested to modify budgets accordingly. If the application is under consideration for funding, NIOSH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIOSH Grant Awards, Subpart A: General (http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm exit EPA)

All NIEHS awards are subject to the NIH terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement. The Grants Policy Statement can be found at http://grants.nih.gov/grants/policy/policy.htm exit EPA. Applications funded by NIEHS requesting up to $250,000 per year in direct costs will have to be reformatted according to the NIH modular budget format. The NIEHS Grants Office prior to the issuance of the award will request reformatting of the budget from the Primary Investigator. The modular budget format simplifies the preparation of the budget in these applications by limiting the level of budgetary detail. Applicants request direct costs in $25,000 modules. Section C of the research grant application instructions for the PHS 398 at http://grants.nih.gov/grants/funding/phs398/phs398.html exit EPA includes step-by-step guidance for preparing modular budgets. Additional information on modular budgets is available at http://grants.nih.gov/grants/funding/modular/modular.htm exit EPA.

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

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

The funding mechanism for all awards issued under this solicitation will consist of assistance agreements from the EPA, NSF, NIEHS, and NIOSH. Any contracts for services or products funded with EPA financial assistance must be awarded under the competitive procurement procedures of 40 CFR Part 30. Moreover, naming a specific contractor in the application does not relieve the applicant of its obligations to comply with competitive procurement requirements. Also, the regulations contain limitations on consultant compensation.

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

Submission Instructions for Paper Applications

The application and abstract must be prepared in accordance with these instructions. The original, signed copy of the application must not be permanently bound or stapled in any way. The other two (2) required copies of the application should be secured with paper or binder clips or secure staples.

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

The following address must be used for regular mail:

U.S. Environmental Protection Agency
Peer Review Division (8725F)
Funding opportunity number: EPA-G2006-STAR-XX
1200 Pennsylvania Avenue, NW
Washington , DC 20460

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

U.S. Environmental Protection Agency
Peer Review Division (8725F)
Funding opportunity number: EPA-G2006-STAR-XX
1025 F Street, NW (Room 3500)
Washington , DC 20004
Phone: (202) 233-0686

Submission Instructions for Electronic Applications Using Grants.gov

The electronic application package available through the http://www.grants.gov/ exit EPA web site must be used for electronic submissions. In order to view the application package, download the PureEdge viewer (hyperlink available under "Apply for Grants" then "Apply Step 1"). The application package may be quickly accessed from https://apply.grants.gov/forms_apps_idx.html exit EPA using either one of the CFDA numbers or one of the Funding Opportunity Numbers. Be sure to download the electronic application package for the appropriate Funding Opportunity Number (research area). It is recommended that you “Register to Receive Notification” of announcement updates. Please note: the electronic application package is available under multiple CFDA numbers because more than one agency is participating in this solicitation. However, any application submitted under a particular Funding Opportunity Number, regardless of the CFDA selected, will be considered admissible for that research area by all participating agencies.

Be sure to download the electronic application package for the appropriate funding opportunity number. It is recommended that you "Register to Receive Notification" of announcement updates.

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

The complete application must be transferred to grants.gov no later than 4:00 pm Eastern Time on the solicitation closing date (see “Submission Dates and Times”). An e-mail will be sent by NCER to the Principal Investigator and the Administrative Contact to acknowledge receipt of the application and to transmit other important information. The email will be sent from receipt.application@epa.gov; email to this address will not be accepted. If an email acknowledgment from NCER (not support@grants.gov) has not been received within 30 days of the submission closing date, immediately contact the Technical Contact listed under “Agency Contacts” in this solicitation. Failure to do so may result in your application not being reviewed.

Documents must be submitted in Adobe Acrobat PDF format to maintain format integrity. Prior to preparing the electronic application package, view files for any PDF conversion errors. Submit the required documents as described below.

On the electronic Grant Application Package page, enter the Principal Investigator’s name, starting with the last name, in the “Application Filing Name” field.

  1. Application for Federal Assistance (SF-424)
    Complete the form. There are no attachments.
  2. EPA Key Contacts Form 5700-54
    1. Complete the form.
    2. If additional pages are needed, see “E. Other Attachments Form” below.
  3. Project Narrative Attachment Form
    1. Compile the Research Plan as described above followed by the Quality Assurance Statement into one document labeled ResearchPlanQA and submit it as the “Add Mandatory Project Narrative File”.
    2. Prepare a document with your abstract, label it Abstract, and submit it as an “Add Optional Project Narrative File”.
    3. Prepare one document containing all Resumes followed by Current and Pending Support (see format example located at http://www.epa.gov/ncer/rfa/forms/), label it Resumes, and submit it as an “Add Optional Project Narrative File”.
  4. Budget Narrative Attachment Form
    1. Where possible, prepare one document for your Budget and Budget Justification (see format example located at http://www.epa.gov/ncer/rfa/forms/), label this document BudgetAndJustification, and submit it as the “Add Mandatory Budget Narrative”.
    2. If you cannot compile your Budget and Budget Justification into one document, prepare one document for each.
      1. Label your Budget document Budget and submit it as the “Add Mandatory Budget Narrative”.
      2. Label the Budget Justification document BudgetJustification and submit it as an “Add Optional Budget Narrative” document.
    3. When submitting letters of intent, first refer to the “Letters of Intent/Letters of Support” paragraph under Section IV. H. (Guidelines, Limitations and Additional Requirements) for additional information. Letters of intent appropriate for inclusion in the budget justification are to be compiled into one document named LettersofIntent and submitted as an “Add Optional Budget Narrative” document.
  5. Other Attachments Form
    1. If Key Contacts Continuation pages are needed for the Key Contacts Form 5700-54, compile them into one document labeled ContactsContinuation and submit the document.
    2. Other appropriate documents may also be submitted here.

Once the application package has been completed, the “Submit” button will become active. Save your completed application package with two different file names before providing it to your AOR to avoid having to re-create the package should submission problems be experienced. Submission of the application package must be completed by your AOR.

Close all other software before attempting to submit the application package. If you experience submission problems, reboot your computer (turning the power off may be necessary) and re-attempt the submission. If submission problems continue, contact grants.gov for assistance (Phone: 1-800-518-4726, Email: support@grants.gov ). If submission problems are not quickly resolved, contact the NCER electronic submission support person, Bronda Harrison (Phone: 202-343-9777, Email: harrison.bronda@epa.gov ).

V. APPLICATION REVIEW INFORMATION

Peer Review Criteria:
An external peer review panel considers an application”s merit based on the criteria below. Criteria 1-8 are listed in descending order of importance:

  1. Research Proposal (criteria “1a” through “1f” are essentially equal):
    1. The originality and creativity of the proposed research, the appropriateness and adequacy of the proposed research methods, and the Quality Assurance Statement.
    2. Is the research approach practical and technically defensible, and can the project be performed within the proposed time period?
    3. Will the research contribute to scientific knowledge in the topic area?
    4. What are the projected benefits of the proposed activity to society, such as improving the environment or human health?
    5. Will the results be disseminated broadly to enhance scientific and technological understanding?
    6. Is the proposal well prepared with supportive information that is self-explanatory or understandable?
  2. Investigators: The qualifications of the Principal Investigator(s) and other key personnel, including research training, demonstrated knowledge of pertinent literature, experience, and publication records. Will all key personnel make a significant time commitment to the project?
  3. Responsiveness: The responsiveness of the proposal to the research needs identified for the topic area. Does the proposal adequately address the objectives and special considerations specified by the EPA for this topic area?
  4. Facilities and equipment: The availability and/or adequacy of the facilities and equipment proposed for the project. Are there any deficiencies that may interfere with the successful completion of the research?
  5. Budget: Although budget information does not reflect on the application”s scientific merit, the reviewers are asked to provide their view on the appropriateness and/or adequacy of the proposed budget and its implications for the potential success of the proposed research. Input on requested equipment is of particular interest.
  6. Inclusions of Women, Minorities, and Children In Research: The adequacy of plans to include subjects from both genders, all racial and ethnic groups (and subgroups), and children as appropriate for the scientific goals of the research. Plans for the recruitment and retention of subjects will also be evaluated. (See Inclusion Criteria in the sections on Federal Citations, below).
  7. Care and Use of Vertebrate Animals In Research: If vertebrate animals are to be used in the project, the five items described under Section f of the PHS 398 research grant application instructions (rev. 5/2001) will be assessed.
  8. Biohazards: If materials or procedures are proposed that are potentially hazardous to research personnel and/or the environment, determine if the proposed protection is adequate.

Programmatic Review and Selection Process
Applications from non-Federal and Federal applicants will be evaluated under the same review/selection process. Proposals from non-Federal applicants that are selected for funding will be funded through assistance agreements under the terms of this solicitation. Proposals from Federal agencies or laboratories deemed acceptable and selected for funding will be funded through a medium other than an assistance agreement, such as inter- or intra-agency transfers, where legal authority exists for such funding. Applications are welcome from all qualified applicants, including in particular Historically Black Colleges and Universities, Hispanic Serving Institutions, other educational institutions with significant minority and/or female enrollment, and Native American Tribal Colleges.

For purposes of EPA awards, EPA will only perform a programmatic review on those applications receiving scores of excellent or very good from the peer review panel. The EPA programmatic review will be 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 proposed research area, and will consider the following factors:

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

The NSF programmatic review will consider the following factors:

For purposes of NIOSH awards, the programmatic review will be conducted by the NIOSH Secondary Review Council and will use the following criteria: magnitude of the problem in terms of numbers of workers affected; severity of the disease or injury in the worker population; other ongoing research projects with similar populations or specific aims; and the likelihood of developing applied technical knowledge for the prevention of occupational safety and health hazards on a national or regional basis. Applications considered of scientific merit and programmatic importance are then recommended for funding to the Director of NIOSH for the final funding decisions.

Under NIEHS and NIH programmatic criteria, the application should support research that will advance understanding of biological systems, improve the control of disease, and enhance health. This review will be conducted by the National Advisory Environmental Health Sciences Council. Funding decisions are made based on recommendations of these review panel groups, programmatic balance and priorities, and availability of funds .and concurrence by the NIEHS National Advisory Environmental Health Sciences Council.

VI. AWARD ADMINISTRATION

Award Notices
Customarily, applicants are notified about award decisions within six months of the application closing date. A summary statement of the scientific review by the peer review panel will be provided to each applicant. After selection for award, applicants recommended for funding will be required to submit additional certifications and an electronic version of the revised project abstract. They may also be asked to provide responses to comments or suggestions offered by the peer reviewers, a revised budget, and/or to make appropriate revisions that serve to strengthen their proposal. Project Officers or other Agency representatives will contact Principal Investigators to obtain these materials.

The official notification of an EPA award will be made by the Agency's Grants Administration Division. Applicants are cautioned that only a grants officer can 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. Before or after an award, applicants may be required to provide additional quality assurance documentation.

Nonprofit applicants recommended for funding by EPA under this announcement will be subject to a preaward administrative capability review consistent with sections 8.b, 8.c, and 9.d of EPA Order 5700.8, EPA Policy on Assessing Capabilities of Non-Profit Applicants for Managing Assistance Awards (http://www.epa.gov/ogd/grants/regulations.htm).

For NIEHS and NIOSH, if the application is under consideration for funding, NIH will request "just-in-time" information from the applicant. For details, applicants may refer to the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General ( http://grants.nih.gov/grants/policy/nihgps_2003/NIHGPS_part4.htm exit EPA). A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization. The NoA signed by the grants management officer is the authorizing document. Once all administrative and programmatic issues have been resolved, the Notice of Award will be generated via email notification from the awarding component to the grantee business official (designated in item 18 on the Application Face Page). If a grantee is not email enabled, a hard copy of the Notice of Award will be mailed to the business official. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs. Additionally, an agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the award notice.

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

For NIEHS and NIOSH, any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIEHS will be handled according to the NIH Grants Policy that can be found at http://grants1.nih.gov/grants/policy/ exit EPA.

 

For NSF dispute policy information, please see the following web link: http://www.nsf.gov/pubs/manuals/gpm05_131/gpm05_131.pdf exit EPA.

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

  1. Meetings: Principal Investigators will be expected to budget for, and participate in, All-Investigators Meetings (also known as progress reviews or grantees' meeting) approximately once per year with EPA, NIOSH, NSH and NIEHS scientists and other grantees to report on research activities and discuss issues of mutual interest.
  2. Approval of Changes after Award: Prior written approval is required from the EPA if there will be significant change from work described in the application. Examples of these changes are contained in 40 C.F.R. 30.25. Note: prior written approval is also required from the EPA for incurring costs more than 90 calendar days prior to award.
  3. Human Subjects: A grant recipient must agree to meet all EPA requirements for studies using human subjects prior to implementing any work with these subjects. These requirements are given in 40 C.F.R. 26, referred to as the “Common Rule”. No work involving human subjects, including recruiting, may be initiated before the EPA has received a copy of the applicant’s Institutional Review Board’s (IRB) approval of the project and the EPA has also provided approval. Where human subjects are involved in the research, the recipient must provide evidence of subsequent IRB reviews, including amendments or minor changes of protocol, as part of annual reports. Until further notice, applications involving intentional dosing of human subjects will not be considered for award by EPA.
  4. Animal Welfare: A grant recipient must agree to comply with the Animal Welfare Act of 1966 (P.L. 89-544), as amended, 7 U.S.C. 2131-2156. The recipient must also agree to abide by the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training” (50 Federal Register 20864-20865. May 20,1985).
  5. (THIS PARAGRAPH DOES NOT APPLY TO NIEHS or NIOSH FUNDED APPLICATIONS) After award, all data (including primary and secondary/existing data) must be made available to the funding agency Project Officer without restriction and be accompanied by comprehensive metadata documentation adequate for specialists and nonspecialists alike to be able to understand how and where the data were obtained and to evaluate the quality of the data. If requested, the data products and their metadata must be provided to the funding agency 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.
  6. Congress, through OMB, has instructed each federal agency to implement Information Quality Guidelines designed to "provide policy and procedural guidance...for ensuring and maximizing the quality, objectivity, utility, and integrity of information, including statistical information, disseminated by Federal agencies." The EPA's implementation may be found at http://www.epa.gov/quality/informationguidelines/. These procedures may apply to data generated by grant recipients if those data are disseminated as described in the Guidelines.

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

  7. Reporting : A grant recipient must agree to provide annual progress reports, with associated summaries for posting on NCER’s web site, and a final report with an executive summary for web posting.
  8. A grant recipient must agree to provide copies of any peer reviewed journal article(s) resulting from the research during the project period. In addition, the recipient should notify the EPA Project Officer of any papers published after completion of the grant that are based on research supported by the grant. NCER posts references to all publications resulting from a grant on the NCER web site.

  9. The funding agency's full or partial support must be acknowledged in journal articles, oral or poster presentations, news releases, interviews with reporters and other communications.

    For EPA awards, any documents developed under the agreement for distribution to the public or inclusion in a scientific, technical, or other journal shall include the following statement:

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

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

VII. AGENCY CONTACTS

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

Eligibility Contact: Tom Barnwell: 202-343-9862; email: barnwell.thomas@epa.gov
Electronic Submissions: Bronda Harrison: 202-343-9777; email: harrison.bronda@epa.gov
Technical Contacts:

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