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Exploratory Research: Nanotechnology Research Grants Investigating Environmental and Human Health Effects of Manufactured Nanomaterials

This is the initial announcement of this funding opportunity.

Sorting Code Number: STAR-2005-B1
Catalog of Federal Domestic Assistance (CFDA) Number: EPA:66.509; NIOSH: 93.262

Solicitation Opening Date: September 20, 2004
Solicitation Closing Date: January 5, 2005
Application Receipt Deadline Date: January 5, 2005

Technical contacts:
-Barbara Karn, PhD; Environmental Protection Agency; Telephone: 202-343-9704; Email: karn.barbara@epa.gov
-Nora Savage, PhD; Environmental Protection Agency; Telephone: 703-347-8104; 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

Eligibility contact:
Thomas Barnwell; Phone: 202-343-9862; email: barnwell.thomas@epa.gov

PARTICIPATING ORGANIZATIONS:

Table of Contents:
SUMMARY OF PROGRAM REQUIREMENTS
Synopsis of Program
Award Information
Eligibility Information
Application Materials
Contact Person(s)
FUNDING OPPORTUNITY DESCRIPTION
Introduction
Background
Specific Areas of Interest
Special Requirements and Opportunities
References
Authority and Regulations
AWARD INFORMATION
ELIGIBILITY INFORMATION
Eligible Applicants
Cost Sharing
APPLICATION AND SUBMISSION INFORMATION
Address to Request Application Package
Content and Form of Application Submission
Sorting Code
Submission Dates and Times
Intergovernmental Review
Funding Restrictions
Other Submission Requirements
APPLICATION REVIEW INFORMATION
Criteria
Review and Selection Process
Anticipated Announcement and Award Dates
AWARD ADMINISTRATION INFORMATION
Award Notices
Administrative and National Policy Requirements
Reporting
AGENCY CONTACTS

Access Standard STAR Forms and Instructions (http://www.epa.gov/ncer/rfa/forms/)
View NCER Research Capsules (http://www.epa.gov/ncer/publications/topical/)
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; and the National Institute for Occupational Safety and Health, (NIOSH), Centers for Disease Control and Prevention (CDC), 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, and exposures of human and other species in natural ecosystems to nanomaterials.

This is the initial announcement for this year’s program. Although not anticipated, should modifications of this announcement be necessary, they will be posted.

Award Information:

Anticipated Type of Award: Grant
Estimated Number of Awards: Approximately 15 to 20 awards
Anticipated Funding Amount: Approximately $7 million total costs depending on availability of funds. EPA intends to commit up to $5,000,000 in fiscal year 2005 (FY05). NIOSH intends to commit up to $1,000,000 in FY05, and NSF intends to commit up to $1,000,000 in FY05.
Cost Sharing: None Required.
Potential Funding per Grant: For a standard grant (e.g., R01-type), 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 total for a three-year period. For an exploratory (e.g., R21-, SGER-type) grant mechanism, an applicant may request a project period of up to two years and a budget for total costs (direct and indirect) not to exceed $200,000 total for a two-year period. Although the financial plans of EPA, NIOSH, and NSF provide support for this program, awards pursuant to this 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:

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 are eligible to apply. See full announcement for more details.

*EPA does not fund these organizations under STAR solicitations

Note: Title 2 United States Code section 1611 states that 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:

The necessary forms for submitting an application in response to this solicitation will be found on the NCER web site, http://www.epa.gov/ncer/rfa/forms.

Contact Persons:

Technical contacts:
-Barbara Karn, PhD; Environmental Protection Agency; Telephone: 202-343-9704; Email: karn.barbara@epa.gov
-Nora Savage, PhD; Environmental Protection Agency; Telephone: 703-347-8104; 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

Eligibility contact:
Thomas Barnwell; Phone: 202-343-9862; email: barnwell.thomas@epa.gov

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) and the National Institute for Occupational Safety and Health’s (NIOSH) support of research on the potential implications of nanotechnology and manufactured nanomaterials on human health and the environment. Research areas of interest include the toxicology, fate, transport and transformation, bioavailability, and human exposures of nanomaterials. Proposals should address one of these topics.

EPA supports research to meet its mission, i.e., “to protect the environment and human health.” Information used in risk assessment, comprised of hazard identification and exposure assessment, is central to EPA’s methods to meet its mission. As such, EPA is interested in funding research on the possible risks and exposure routes of newly produced chemicals and materials at the nanoscale.

At NSF, proposals are solicited that 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 research ideas, application of new expertise or new approaches to “established” research topics.

NIOSH supports research 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.

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 as follows: “Research and technology development at the atomic, molecular or macromolecular levels, in the length scale of approximately 1 - 100 nanometer range, to 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 under control of the nanoscale structures and their integration into larger material components, systems and architectures. Within these larger scale assemblies, the control and construction of their structures and components remains at the nanometer scale. In some particular cases, the critical length scale for novel properties and phenomena may be under 1 nm (e.g., manipulation of atoms at ~0.1 nm) or be larger than 100 nm (e.g., nanoparticle-reinforced polymers have the unique feature at ~ 200 - 300 nm as a function of the local bridges or bonds between the nano particles and the polymer).” (See http://www.nano.gov exit EPA for more information.)

Many industries are currently involved in nanotechnology-related activities. Among these activities is 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 manufactured nanoscale materials 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 environmental exposures of humans and other organisms to nanoscale materials.

There is a serious lack of information about the human health and environmental implications of manufactured nanomaterials, e.g., nanoparticles, nanotubes, nanowires, fullerene derivatives, and other nanoscale materials. Table 1 provides an outline of nanostructures, their size, and material into which they may be formed, indicating the type of application in which they may be used. Environmental and other safety concerns about nanotechnology have been raised (Dagani, 2003; Masciangoli and Zhang, 2003; Service, 2003). As part of EPA's and NIOSH’s mission to protect human health and the environment, this solicitation requests research proposals which address potential health and environmental concerns of nanomaterials using the best science available, in keeping with NSF’s and the other agencies’ missions.

Potentially harmful effects of nanotechnology might arise as a result of the nature of the nanoparticles themselves, the characteristics of the products made from them or aspects of the manufacturing process involved. The large surface area, crystalline structure, and reactivity of some nanoparticles may facilitate transport in the environment or lead to harm because of their interactions with cellular material. In the case of nanomaterials, size matters and could facilitate and exacerbate any harmful effects caused by the composition of the material.

Some research has been done on inhalation and dermal exposure to nanoparticles. However, the current research on ultrafine particles may not be applicable to manufactured nanoparticles because the ultrafine materials studied are neither a consistent size nor pure in chemical or structural composition. Exposure may occur via the dermal and ingestion, as well as inhalation routes. It is unknown whether nanomaterials bioaccumulate and, thereby, pose human health and environmental risks because of this potential property.

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 disposed of, these materials could have harmful effects as they move through the environment.

Specific Areas of Interest

The RFA sponsors are particularly interested in supporting research related to manufactured nanomaterials in the following areas: (1) toxicology of manufactured nanomaterials; (2) fate, transport, and transformation of manufactured nanomaterials; and (3) human exposure and bioavailability.

(1) Toxicology of manufactured nanomaterials

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?

(2) Environmental and biological fate, transport, and transformation of manufactured nanomaterials

Information about fate, transport, and transformation is necessary to estimate exposure. Relevant research questions might include but are not limited to: By what means do (can) manufactured nanomaterials enter the environment? What are the modes of dispersion for nanomaterials in the environment? Do manufactured nanoparticles undergo transformation in the environment? Do manufactured nanoparticles bioaccumulate through the food chain?

(3) Exposure and bioavailability of manufactured nanomaterials

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 engineering controls and personnel protective equipment? What releases might occur from the manufacturing processes of nanomaterials? At what stage in the product lifecycle might exposure occur? 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?

Special Requirements And Opportunities

Because the manufacturing of nanomaterials is not 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.
Researchers are encouraged to explore the appropriateness and availability of special nanotechnology user facilities at the Department of Energy. Information can be found at: http://www.nano.gov/html/centers/DOEcenters.html exit EPA. The National Institute of Standards and Technology (NIST) also offers user facilities. See http://www.nano.gov/html/centers/NISTcenters.html exit EPA for information. NSF has user facilities under the National Nanotechnology Infrastructure Network program (http://www.nnin.org/ exit EPA).

References

Table 1. Examples of nanostructured materials
Nanostructure Size Example Material or Application
Clusters, nanocrystals, quantum dots radius: 1-10 nm insulators, semiconductors, metals, magnetic materials
Other nanoparticles radius: 1-100 nm ceramic oxides
Nanowires diameter: 1-100 nm metals, semiconductors, oxides, sulfides, nitrides
Nanotubes diameter: 1-100 nm Carbon, including fullerenes, layered chalcogenides

Adapted from J.Jortner and C.N.R.Rao, 2002.

General References

Dagani, R. Nanomaterials: 2003. Safe or Unsafe? Chemical and Engineering News 81(17):30-33.

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.

Service, RF. 2003. Nanomaterials Show Signs of Toxicity. Science 300(5617):24.US Congress. 2003. House of Representatives. Committee on Science Hearing: The Societal Implications of Nanotechnology. April 9, 2003, 2318 Rayburn House Office Building. (http://www.house.gov/science/hearings/full03/index.htm exit EPA

Authority and Regulations

The EPA authority for this RFA and resulting awards is contained in the National Nanotechnology Act, Clean Air Act, Section 103, as amended, Public Law 95-95, 42 U.S.C. 7401 et seq.; the Clean Water Act, Section 104, as amended, Public Law 95-217, 33 U.S.C. 1251 et seq., Solid Waste Disposal Act, Section 8001, as amended 42 U.S.C. 6981; Toxic Substances Control Act, Section 10, as amended 15 U.S.C. 2609; and Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, as amended 7 U.S.C. 136r.

For NIOSH, this program is described in the Catalog of Federal Domestic Assistance at http://www.cfda.gov/ exit EPA and is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. 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.

AWARD INFORMATION

It is anticipated that a total of approximately $7 million will be awarded, depending on the availability of funds. EPA intends to commit up to $5,000,000 in fiscal year 2005 (FY05). NIOSH intends to commit up to $1,000,000 in FY05, and NSF intends to commit up to $1,000,000 in FY05. Depending on the proposal types, 16-20 awards may be given.

For a standard grant (e.g., RO1-type), 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 total for a three-year period. For an exploratory (e.g., R21-, SGER-type) grant mechanism, an applicant may request a project period of up to two years and a budget for total costs (direct and indirect) not to exceed $200,000 total for a two-year period. Although the financial plans of EPA, NIOSH, and NSF provide support for this program, awards pursuant to this 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

Eligible Applicants

Institutions of higher education and not-for-profit institutions located in the U.S., and Tribal, state and local governments, are eligible to apply. Universities and educational institutions must be subject to OMB Circular A-21. Profit-making firms are not eligible to receive grants from EPA under this program. However, profit-making firms and faith-based community-based organizations, and eligible agencies of the Federal government are eligible for awards from NIOSH. Cost sharing is encouraged but not required.

Eligible nonprofit organizations include any organizations that meet the definition of nonprofit in OMB Circular A-122. However, nonprofit organizations described in Section 501(c)(4) of the Internal Revenue Code that engage in lobbying activities as defined in Section 3 of the Lobbying Disclosure Act of 1995 are not eligible to apply.

National laboratories funded by federal agencies (Federally-funded Research and Development Centers, “FFRDCs”) may not apply. FFRDC employees may cooperate or collaborate with eligible applicants within the limits imposed by applicable legislation and regulations. They may participate in planning, conducting, and analyzing the research directed by the principal investigator, but may not direct projects on behalf of the applicant organization or principal investigator. The principal investigator's institution, organization, or governance may provide funds through its grant from EPA to a FFRDC for research personnel, supplies, equipment, and other expenses directly related to the research. However, salaries for permanent FFRDC employees may not be provided through this mechanism.

Under EPA guidelines, Federal agencies may not apply. However, some agencies of the Federal government are eligible under NIOSH guidelines. (Please direct eligibility inquiries to Tom Barnwell, US EPA, phone: 202-343-9862; email: barnwell.thomas@epa.gov.) Federal employees are not eligible to serve in a principal leadership role on a grant, and may not receive salaries or in other ways augment their agency's appropriations through grants made by this program. Nonetheless, federal employees may interact with grantees so long as their involvement is not essential to achieving the basic goals of the grant. EPA encourages interaction between its own laboratory scientists and grant principal investigators for the sole purpose of exchanging information in research areas of common interest that may add value to their respective research activities. This interaction must be incidental to achieving the goals of the research under a grant. Interaction that is “incidental” does not involve resource commitments.

The principal investigator’s institution may enter into an agreement with a Federal agency to purchase or utilize unique supplies or services unavailable in the private sector. Examples are purchase of satellite data, census data tapes, chemical reference standards, analyses or use of instrumentation or other facilities not available elsewhere. A written justification for Federal involvement must be included in the application, along with an assurance from the federal agency involved which commits it to supply the specified service.

Any individual with the skills, knowledge, and resources necessary to carry out the proposed research are invited to work with their institutions to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for Federal programs.

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

Cost Sharing

Institutional cost sharing is not required and, therefore, does not have to be included in the budget table. However, if the applicant intends to cost share, a brief statement concerning cost-sharing should be added to the budget justification, and estimated dollar amounts must be included in the appropriate categories in the budget table.

APPLICATION AND SUBMISSION INFORMATION

Address to Request Application Package

Application forms and instructions for applying can be found on the NCER web site at: http://www.epa.gov/ncer/rfa/forms/.

Content and Form of Application Submission

This RFA will use EPA, NIOSH and NSF award mechanisms. For those projects funded by EPA and NIOSH, the standard research project grant (e.g., R01-type) award mechanism or the Exploratory/Pilot Developmental (e.g., R21-type) award mechanism will be utilized. The standard R01-type mechanism is suggested for applications that propose basic or applied research in which preliminary data exist or there is a high probability of success. The exploratory R21-type mechanism is suggested for applications that have little or no preliminary data and are exploratory or pilot in focus. Those proposals selected for an NSF award will be re-submitted by the applicant to NSF through FastLane and follow published Proposal Grant Guidelines per http://www.nsf.gov/pubs/gpg/nsf04_23/nsf04_23.pdf (PDF, 61pp., 403.15 KB)about PDF). exit EPA

This RFA uses the detailed budget format and justification.

The initial application is made through submission of the materials described below. It is essential that the application contain all information requested and be submitted in the formats described. Noncompliance with formatting instructions (page limits, font size, etc.) is grounds for administrative dismissal. Please note that if an application is being considered for an award (i.e., after external peer review and internal review), additional forms and other information will be requested by the EPA Project Officer. The application must contain the following:

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

Regarding Block 16 of the SF 424: research funded under this program may be eligible under E.O. 12372, “Intergovernmental Review of Federal Programs,” if it affects public health or if an environmental impact statement is required. If applicable, an applicant should consult the office or official designated as the single point of contact in his or her state for more information on the process the state requires to be followed in applying for assistance, if the state has selected the program for review.

B. Key Contacts: The applicant must complete the Key Contacts Form (NCER Form 1) as the second page of the application. The Key Contacts Form and a continuation page are available at http://www.epa.gov/ncer/rfa/forms. A copy of this form should also be completed for major sub-agreements (contacts at the institutions of primary co-investigators). Please make certain that all contact information is accurate. An e-mail will be sent by NCER (from receipt.application@epa.gov; e-mails to this address are not accepted) to the Principal Investigator (with a copy to the Administrative Contact) to acknowledge receipt of the application and to transmit other important information. If an e-mail acknowledgment has not been received within 30 days of the submission deadline, then immediately contact the project officer listed under "Contacts" in this solicitation. Please note: Due to often lengthy delays in delivery, it is especially important that you monitor NCER confirmation of receipt of your application when using regular mail.

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

D. Abstract: The abstract is a very important document. All abstracts are provided to the peer review panelists, and some of the panelists may read only the abstract. Abstracts also play a critical role in programmatic review (see “Application Review Information”). Therefore, it is critical that the abstract accurately describe the research being proposed and convey all the essential elements of the research. Also, the abstracts of applications that receive funding will be posted on the NCER web site.

The abstract, limited to one page, should include the information indicated in the example format (http://www.epa.gov/ncer/rfa/forms) and described below (1-8). Examples of abstracts for current grants may be found on the NCER web site.

  1. Research Category and Sorting Code: Enter the full name of the solicitation under which your application is submitted and the code that corresponds to the appropriate RFA topic.
  2. Title: Use the exact title of your project as it appears in the application. The title must be brief, yet represent the major thrust of the project. Because the title will be used by those not familiar with the project, strike a balance between highly technical words and phrases and more commonly understood terminology. Do not use phrases such as “research on.”
  3. Investigators: List the Principal Investigator, then the names and affiliations of each co-investigator who will significantly contribute to the project. Provide a web site URL or an E-Mail contact address for additional information.
  4. Institution: In the same order as the list of investigators, list the name and city/state of each participating university or other applicant institution. The institution applying for assistance must be clearly identified.
  5. Project Period: Show the proposed project beginning and ending dates.
  6. Project Cost: Show the total dollar request, including direct and indirect costs, to the EPA for all grant years (the entire project period).
  7. Project Summary: Provide three subsections addressing: (a) the objectives of the study (including any hypotheses that will be tested), (b) the experimental approach to be used (a description of the project proposed), and (c) the expected results of the project and how it addresses the research needs identified in the solicitation, including the estimated improvement in risk assessment or risk management that will result from successful completion of the proposed work.
  8. Supplemental Keywords: Supply keywords to assist database searchers in finding your research, without duplicating terms already used in the text of the abstract. A complete set of keywords is very important. A list of suggested keywords will be found at http://www.epa.gov/ncer/rfa/forms.

E. Research Plan and Quality Assurance Statement

Research Plan:

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

This description must not exceed fifteen (15) consecutively numbered (bottom center), 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins. The description must provide the following information:

  1. Objectives: List the objectives of the proposed research and the hypotheses being tested during the project, and briefly state why the intended research is important. This section should also include any background or introductory information that would help explain the objectives of the study. If this application is for continuation of research supported by an existing or former grant awarded under the STAR program, indicate the number of the grant and provide a brief report of progress and results achieved under that grant (one to two pages recommended).
  2. Approach: Outline the research design, methods, and techniques that you intend to use in meeting the objectives stated above (five to 10 pages recommended).
  3. Expected Results or Benefits: Describe the results you expect to achieve during the project and the benefits of the results. This section should also discuss how the research results will lead to solutions to environmental problems and improve the public’s ability to protect the environment and human health. A clear, concise description will help NCER understand the merits of the research (one to two pages recommended).
  4. General Project Information: Discuss other information relevant to the potential success of the project. This should include facilities, personnel, project schedules, proposed management, interactions with other institutions, etc. Applications for multi-investigator projects must identify project management and the functions of each investigator within a team and describe plans for communication and sharing of data (one to two pages recommended).
  5. Important Attachments:

References cited are in addition to the 15-page Research Plan limit.

Letters of intention that are limited to one brief paragraph merely assuring commitment of a resource (e.g., use of a person’s time or equipment) not under the control of the applicant institution may be included and are in addition to the 15 pages.

Letters of intention that exceed one brief paragraph will be considered a part of the appendix.

Appendices may be included but must remain within the 15-page limit.

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

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

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

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

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

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

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

F. Budget and Budget Justification:

Budget:

Prepare a budget table using the guidance and format found at http://www.epa.gov/ncer/rfa/forms/, select “All required forms.” If a sub-agreement, such as a subcontract, is included in the application, provide a separate budget for the subcontract in the same format. 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 subagreements must be provided, discussing the need for this agreement to accomplish the objectives of the research project.

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

Budget Justification:

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

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

  1. Personnel: List all staff positions by title. Give annual salary, percentage of time assigned to the project, and total cost for the budget period.
  2. Fringe Benefits: Identify the percentage used and the basis for its computation.
  3. Travel: Specify the estimated number of trips and locations, and other costs for each type of travel. Explain the need for any travel outside the United States. Include travel funds for annual STAR program progress reviews and a final workshop to report on results.
  4. Equipment: Identify computers, and each item to be purchased which has an estimated cost of $5,000 or more per unit and a useful life of more than one year. (Items with a unit cost of less than $5,000 are considered supplies, per regulation.)
  5. Supplies: “Supplies” means all tangible property other than “equipment.” Identify categories of supplies to be procured (e.g., laboratory supplies or office supplies).
  6. Contractual: Identify each proposed sub-agreement (grant or contract) and specify its purpose and estimated cost. Sub-agreements more than $25K should have a separate itemized budget included as part of the application.
  7. Other: List each item in sufficient detail for the EPA to determine the reasonableness of its cost relative to the research to be undertaken.
  8. Indirect Charges: If indirect charges are included in the budget, indicate the approved rate and base with an explanation of how indirect costs were calculated.

G. Resumes and Current and Pending Support

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

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

H. Guidelines, Limitations, and Additional Requirements

Confidentiality

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

Sorting Code

At various places within the application, applicants are asked to identify the sorting code.

The sorting code must be placed at the top of the abstract (location is shown in the abstract format, http://www.epa.gov/ncer/rfa/forms), in Box 10 of Standard Form 424, and in the address on the package that is sent to the EPA (see below). The sorting code for this RFA is: STAR-2005-B1.

Submission Dates and Times

The original and eight (8) copies of the complete application (9 in all) and one (1) additional copy of the abstract, must be received by NCER no later than 4:00 P.M. Eastern Time on the closing date assigned to this topic area. The following is the schedule for this RFA. It should be noted that this schedule may be changed without prior notification due to factors that were not anticipated at the time of announcement. In the case of a change in the required receipt date, the new date will be posted on the NCER website.

Application Receipt Date: January 5, 2005

Earliest Anticipated Start Date: June 2005

To be considered timely, applications and initial proposals must be received by the Agency on or before the deadline date published in the RFA. Applications received after the published deadline or applications that deviate from the prescribed format will be returned to the sender without further consideration. Also, applications exceeding the funding limits described in the RFA will be returned without review.

Intergovernmental Review

Research funded under this program may be eligible under E.O. 12372, “Intergovernmental Review of Federal Programs,” if it affects public health or if an environmental impact statement is required. If applicable, an applicant should consult the office or official designated as the single point of contact in his or her state for more information on the process the state requires to be followed in applying for assistance, if the state has selected the program for review. The names and addresses of the state’s single point of contact are listed in the OMB home page at http://www.whitehouse.gov/omb/grants/spoc.html. exit EPA

Funding Restrictions

Applicants will be expected to budget for and participate in an annual All-Investigators’ Meeting with EPA, NIOSH, and NSF and other grantees to report on research activities and to discuss relevant issues. The purpose of this meeting is to provide an opportunity for the exchange and dissemination of scientific information and help build the community of investigators in nanotechnology who consider the environment and human health effects in their research.

The funding mechanism for all awards issued under EPA STAR solicitations will consist of assistance agreements from the EPA. All award decisions are subject to the availability of funds. In accordance with Public Law 95-224, the primary purpose of a grant is to accomplish a public purpose of support or stimulation authorized by Federal statute, rather than acquisition for the direct benefit or use of the Agency. In issuing a grant agreement, the EPA anticipates that there will be no substantial EPA involvement in the design, implementation or conduct of the research. However, the EPA will monitor research progress through annual reports provided by grantees and other contacts, including site visits, with the Principal Investigator.

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

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

Other Submission Requirements

The application and abstract must be prepared in accordance with these instructions. Informal, incomplete or unsigned applications will be returned without review. The original, signed copy of the application must not be bound or stapled in any way. The other eight (8) required copies of the application should be secured with paper or binder clips or secure staples.

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

The following address must be used for regular mail:

U.S. Environmental Protection Agency
Peer Review Division (8725F)
Sorting Code: STAR-2005-B1
1200 Pennsylvania Avenue, NW
Washington, D.C. 20460

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

U.S. Environmental Protection Agency
Peer Review Division (8725F)
Sorting Code: STAR-2005-B1
1025 F Street, NW (Room 3500)
Washington, DC 20004
Phone: (202) 233-0686

APPLICATION REVIEW INFORMATION

Upon receipt, applications will be reviewed for completeness and responsiveness by EPA, NSF, and NIOSH. Incomplete applications will not be reviewed. If the application is not responsive to the RFA, the application may be returned.

Applications that are complete and responsive to the RFA will be evaluated for scientific and technical merit by a scientific review group convened by EPA, NSF and NIOSH in accordance with the review criteria stated below. As part of the initial merit review, all applications will:

  • Undergo a process in which only those applicants deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed and assigned a priority score
  • Receive a written critique
  • Receive a second level of review for programmatic importance by EPA, NIOSH, and NSF in order to assign grants for funding according to each Agency’s programmatic priorities.

Criteria

EPA’s review criteria.

Consideration of an application’s merit is based on the following criteria: All else being equal, proposals that consider multiple environmental benefits will be ranked higher than those that consider only single benefits, and proposals that involve an interdisciplinary team of researchers will be ranked higher than those that include only a single discipline. EPA’s criteria include:

  1. The originality and creativity of the proposed research, the appropriateness and adequacy of the research methods proposed, and of the Quality Assurance Statement. Is the research approach practical and technically defensible, and can the project be performed within the proposed time period? Will the research contribute to scientific knowledge in the topic area? Will the results be disseminated broadly to enhance scientific and technological understanding? What may be the benefits of the proposed activity to society? Is the proposal well-prepared with supportive information that is self-explanatory or understandable?
  2. The qualifications of the principal investigator(s) and other key personnel, including research training, demonstrated knowledge of pertinent literature, experience, and publication records. Will all key personnel make a significant time commitment to the project?
  3. The responsiveness of the proposal to the research needs identified for the topic area. Does the proposal adequately address the objectives specified by the EPA for this topic area?
  4. The availability and/or adequacy of the facilities and equipment proposed for the project. Are there any deficiencies that may interfere with the successful completion of the research?
  5. Although budget information does not reflect on the application’s scientific merit, the reviewers are asked to provide their view on the appropriateness and/or adequacy of the proposed budget and its implications for the potential success of the proposed research. Input on requested equipment is of particular interest.

NSF’s review criteria are:

  1. What is the intellectual merit of the proposed activity? How important is the proposed activity to advancing knowledge and understanding within its own field or across different fields? How well qualified is the proposer (individual or team) to conduct the project? (If appropriate, the reviewer will comment on the quality of prior work.) To what extent does the proposed activity suggest and explore creative and original concepts? How well conceived and organized is the proposed activity? Is there sufficient access to resources?
  2. What are the broader impacts of the proposed activity? How well does the activity advance discovery and understanding while promoting teaching, training, and learning? How well does the proposed activity broaden the participation of underrepresented groups (e.g., gender, ethnicity, disability, geographic, etc.)? To what extent will it enhance the infrastructure for research and education, such as facilities, instrumentation, networks, and partnerships? Will the results be disseminated broadly to enhance scientific and technological understanding? What may be the benefits of the proposed activity to society?

NIOSH review criteria include:

  1. SIGNIFICANCE: Does this study address an important problem? If the aims of the application are achieved, how will scientific knowledge be advanced? What will be the effect of these studies on the concepts or methods that drive this field?
  2. APPROACH: Are the conceptual framework, design, methods, and analyses adequately developed, well-integrated, and appropriate to the aims of the project? Do you acknowledge potential problem areas and consider alternative tactics?
  3. INNOVATION: Does your project employ novel concepts, approaches or methods? Are the aims original and innovative? Does the project challenge existing paradigms or develop new methodologies or technologies?
  4. INVESTIGATOR: Is the investigator appropriately trained and well-suited to carry out this work? Is the work proposed appropriate to your experience level of the principal investigator and other researchers (if any)?
  5. ENVIRONMENT: Does the scientific environment in which your work will be done contribute to the probability of success? Do the proposed experiments take advantage of unique features of the scientific environment or employ useful collaborative arrangements? Is there documentation of cooperation from industry, unions, communities, or other participants in the project, where applicable? Is there evidence of institutional support?

    Under NIOSH criteria, the application does not need to be strong in all categories to be judged likely to have major scientific impact and thus deserve a high priority score. For example, an investigator may propose to carry out important work that by its nature is not innovative but essential to move a field forward.

Additional NIOSH considerations are:

  • Protections of Human Subjects From Research Risk: The involvement of human subjects and protections from research risk relating to their participation in the proposed research will be assessed. (See criteria included in the section on Federal Citations, below).
  • 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).
  • 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.

Additional Review Considerations

  • Budget: The reasonableness of the proposed budget and the requested period of support in relation to the proposed research.
  • Availability of special opportunities for furthering research programs through the use of unusual talent resources, populations, or environmental conditions in other countries which are not readily available in the United States or which provide augmentation of existing U.S. resources.

Review and Selection Process

For grant administration, grant applications will be submitted to and processed by EPA. After peer review and discussion with other participating agencies, applications selected for funding will be reassigned to the agency where they are programmatically most appropriate.

All grant applications are reviewed by an appropriate external technical peer review panel. In general, each peer review group is composed of non-EPA scientists, engineers, social scientists, and/or economists who are experts in their respective disciplines and are proficient in the technical subjects they are reviewing. Reviewers are asked to assign a summary score of excellent, very good, good, fair, or poor to each application. This review is designed to evaluate each proposal according to its scientific merit.

Applications that receive scores of excellent and very good from the peer reviewers are subjected to a programmatic review within the Agencies to ensure a balanced research portfolio for the Agency. The programmatic review considers the relevance of the proposed science to Agency research priorities, program balance, budget, and available funds. NIOSH considers: the 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. Selected applications are then recommended for funding to the appropriate Official within each Agency responsible for the final funding decisions. Selected applicants will be required to provide additional information and the application will be forwarded to the grants administration office for award in accordance with each Agency’s procedures.

Anticipated Announcement and Award Dates

The following is the schedule for this RFA. Please note that this schedule may be changed without notification due to factors that were not anticipated at the time of announcement.

Application Receipt Date: January 5, 2005
Earliest Anticipated Start Date: June 2005

The anticipated award date is on or before June 15, 2005.

AWARD ADMINISTRATION INFORMATION

Award Notices

Customarily, applicants are notified about award decisions within six months of the application deadline. A summary statement of the scientific review by the peer panel will be provided to each applicant with the award or declination letter. After selection for award, applicants recommended for funding will be required to submit additional certifications and an electronic version of the revised project abstract, and may be requested to provide responses to comments or suggestions offered by the peer reviewers, a revised budget, and/or to resubmit their proposal. Agency Project Officers will contact Principal Investigators to obtain these materials. The official notification of an award will be made by the Agency’s grants administration office. Before or after an award, certain applicants will be expected to provide additional quality assurance documentation.

Administrative and National Policy Requirements

This RFA is a joint announcement by EPA, NSF, and NIOSH and reflects the common research interests of the participating Agencies. This program will be managed by the three Agencies as a unified program, although the grants will be awarded by each Agency separately.

Policies that govern grant award programs of each participating Agency will prevail for the respective sources of support. As an applicant you will be solely responsible for planning, directing, and executing the proposed project. This RFA is a one-time solicitation with the possibility for reissue.

Expectations and responsibilities of NCER grantees are summarized in this section; see http://www.epa.gov/ncer/guidance for full terms and conditions associated with an award, including what activities require prior approval of the EPA.

A. Meetings: Principal Investigators will be expected to budget for, and participate in, periodic All-Investigators Meetings (also known as progress reviews) approximately once per year with EPA, NIOSH, and NSF scientists and other grantees to report on research activities and to discuss issues of mutual interest.

B. Approval of Changes after Award: Prior written approval is required from the Agency if there is to be significant change in the research that deviates markedly from work described in the application. Examples of these changes are contained in 40 C.F.R. 30.25. Prior written approval is also required from the Agency for incurring costs greater than 90 calendar days prior to award.

C. Human Subjects: A grant recipient must agree to meet all Agency 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 Agency has received a copy of the applicant’s Institutional Review Board’s (IRB) approval of the project and the Agency has also provided approval. Where human subjects are involved in the research, the recipient must provide evidence of subsequent IRB reviews, including amendments or minor changes of protocol, as part of annual reports.

D. Animal Welfare: A grant recipient must agree to comply with the Animal Welfare Act of 1966 (P.L. 89-554), as amended. All projects involving vertebrate animals must have approval from the applying organization’s Institutional Animal Care and Use Committee before issuance of an Agency grant.

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

EPA Reporting

A grant recipient must agree to provide annual progress reports with associated summaries for posting on the EPA’s web site, and a final report with an executive summary for web posting.

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

The EPA’s full or partial support should be acknowledged in journal articles, oral or poster presentations, news releases, interviews with reporters and other communications. For example, any documents developed under an agreement with EPA for distribution to the public or inclusion in a scientific, technical, or other journal shall include the following statement:

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

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

AGENCY CONTACTS

We encourage inquiries concerning this RFA and welcome the opportunity to answer questions from potential applicants. Inquiries may fall into three areas: scientific/research, peer review, and financial or grants management issues. This RFA may be found on the following web pages:

http://www.epa.gov/ncer/
http://www.nsf.gov exit EPA
http://www.cdc.gov/ exit EPA, under the "Funding" section (see "Grants and Cooperative Agreements" scroll down to "Occupational Safety and Health http://www.cdc.gov/niosh/homepage.html exit EPA, under "Extramural Programs", "Current Funding Opportunities".

Direct your questions regarding scientific/research issues to:

Barbara Karn, PhD
Environmental Protection Agency
Telephone: 202-343-9704
Email: karn.barbara@epa.gov

Nora Savage, PhD
Environmental Protection Agency
Telephone: 703-347-8104
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
1600 Clifton Road, N.E.
Executive Park Building 24, Room 1427, MS E-74
Atlanta, GA 30333
Telephone: 404/498-2509
FAX: 404/498-2571
Email: ahc0@cdc.gov

Direct your questions about eligibility issues to:

Thomas O. Barnwell, Jr.
Senior Science Advisor
National Center for Environmental Research
US EPA
Telephone: 202-343-9862
Email: Barnwell.Thomas@epa.gov

 

 

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