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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

DEVELOPMENT AND EVALUATION OF INNOVATIVE APPROACHES FOR THE QUANTITATIVE ASSESSMENT OF PATHOGENS IN DRINKING WATER

Special Announcement

The Submission Instructions for Electronic Applications section of this RFA has been updated.

This revision is provided primarily for clarification of previous instructions as well as to provide additional assistance during the application transmittal process. No modification of applications in preparation is required (i.e., updating the Application Filing Name is optional). These changes include:

  1. the hyperlink location for the PureEdge viewer
  2. further emphasis that the Authorized Organization Representative (AOR) must submit the application package
  3. emphasis that e-mails from grants.gov do not document receipt of the application by NCER; NCER receipt is necessary to assure review
  4. new instruction as to what is appropriate to put in the "Application Filing Name" field
  5. clarification that the application can be submitted after "Submit" button activation
  6. some trouble-shooting advice to avoid/resolve problems commonly observed when first attempting to transfer the file to grants.gov (i.e., close all other software, reboot computer)
  7. a phone number for grants.gov

Note that only the submission instructions for electronic applications has been changed and that these changes are designed only to make the filing process more clear.

This is the May 10, 2005 update of this funding opportunity. This revision is to update the Submission Instructions for Electronic Applications section only. This update is provided for clarification of previous instructions a well as to provide additional assistance during the application transmittal process. No modification of applications in preparation is required (i.e., updating the application Filing Name is optional).

Sorting Code Numbers: 2005-STAR-K1
Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: March 3, 2005
Solicitation Closing Date: June 9, 2005
Application receipt deadline date: June 9, 2005, 4:00 p.m. E.T.

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

Technical Contacts:
Cynthia Nolt-Helms; Phone: 703-347-8102; Email: nolt-helms.cynthia@epa.gov
Angela D. Page; Phone 703-347-8046; Email: page.angelad@epa.gov

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

Access Standard STAR Forms and Instructions
View NCER Research Capsules
View previous solicitations
View research awarded under previous solicitations

SUMMARY OF PROGRAM REQUIREMENTS

Synopsis of Program:

The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications proposing development and evaluation of innovative approaches to quantitatively detect microbial pathogens in drinking water. The purpose of this request for applications is to improve the suite of available detection methods for known and emerging microbial drinking water contaminants.

EPA is seeking research proposals that:

  • determine the occurrence of and enumerate waterborne pathogens;
  • present a protocol for preparing and processing water samples for application of the proposed approach; and
  • where possible, compare the performance of the new detection method with existing approved EPA methods for determining the presence of specific pathogens.

The goal of this request for applications (RFA) is the development and evaluation of innovative approaches to quantitatively detect microbial pathogens in drinking water.

Award Information:

Anticipated Type of Award: Grant
Estimated Number of Awards: Approximately 7-10 awards
Anticipated Funding Amount: Approximately $5 million total for all awards
Potential Funding per Grant: Up to $200,000/year with a duration of 2 or 3 years and no more than a total of $600,000, including direct and indirect costs. Cost-sharing is not required. Proposals with budgets exceeding the total award limits will not be considered.

Eligibility Information:

Institutions of higher education and not-for-profit institutions located in the U.S., and tribal, state and local governments, are eligible to apply. See full announcement for more details.

Application Materials:

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

Contact Person(s):

Technical Contacts: Cynthia Nolt-Helms; Phone: 703-347-8102; Email: nolt-helms.cynthia@epa.gov or Angela D. Page; Phone 703-347-8046; email: page.angelad@epa.gov

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

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

Do not attempt to seek information regarding this RFA from any source other that those contacts identified above as the information provided may not be accurate.

I. FUNDING OPPORTUNITY DESCRIPTION

Introduction

One of the high-priority research areas being addressed by EPA’s Office of Research and Development (ORD) is drinking water. Under the 1996 Amendments to the Safe Drinking Water Act (SDWA), the responsibility for ensuring that public water systems provide safe drinking water is shared among EPA, States, Tribal Nations, and water systems. Threats to drinking water safety may come from chemical and microbial contaminants. Research is needed in a variety of areas to improve safety assessments, and, thereby reduce the public health risks from contaminants in public water systems in the United States.

ORD has also developed a Multi-Year Plan for Drinking Water Research (USEPA, 2003) that identifies drinking water-related research ORD plans to carry-out over the next 5 years. This will be undertaken in EPA’s intramural program, including three national laboratories, and one national center, and in the extramural program through Science to Achieve Results (STAR) grants. EPA currently supports a number of drinking water-related research grants resulting from previous solicitations and details of these efforts can be found on ORD’s National Center for Environmental Research (NCER) homepage http://www.epa.gov/ncer.

The specific EPA Strategic Goal, Objective and Sub-objective that relates to this solicitation is: Goal 2: Clean and Safe Water, Objective: 2.3 Enhance Science and Research, Sub-objective: 2.3.2 Conduct Leading-Edge Research. EPA’s Strategic Plan can be found on the following webpage: http://www.epa.gov/ocfo/plan/2003sp.pdf. (PDF, 239pp., about PDF)

Background

A major requirement of the 1996 Safe Drinking Water Act (SDWA) Amendments [section 1412(b)(1)] requires EPA to publish, every five years, a list of unregulated contaminants known or anticipated to occur in drinking water that may pose a public health risk. This list has subsequently become known as the Contaminant Candidate List (CCL). The first CCL was published in March 1998 {63 Fed. Reg. 10274 (March 2, 1998)} and consisted of 50 chemicals and 10 microbial contaminants/contaminant groups. The second CCL was issued in the Federal Register in February 2005 {70 Fed. Reg. 9071 (February 24, 2005)} and consists of 42 chemicals and nine microbial contaminants. The second CCL repeats the first CCL without the nine contaminants for which EPA made the determination not to regulate in 2003 {68 Fed. Reg. 42897 (July 18, 2003)}.

The microbial components on the CCL list are those not currently regulated which may have the greatest potential to cause harm via drinking water. Pathogens in drinking water are of concern because they are associated with waterborne disease. Both the incidence of waterborne disease in the U.S. and the causative agent for a disease outbreak are often uncertain. An analysis of outbreak data from 1991-98 revealed that for 41% of the disease outbreaks, an infectious etiological agent was suspected, but the cause remained undetermined (Craun et al. 2002). While the microbial quality of drinking water can be evaluated using a bacterial indicator approach, this approach does not provide an accurate picture of the pathogenic viruses, bacteria, and protozoa that might be present. Direct culturing, the conventional detection approach frequently considered the “gold standard,” can take several weeks to accurately identify a pathogenic strain and has been found to underestimate the densities and diversity of microorganisms in all types of water samples (Amann et al., 1995; Szewzyk et al., 2000). An additional consideration for pathogens in drinking water is the need to determine the viability and infectivity of the pathogen (Ford, 1999). Presence of genetic material alone is not adequate to demonstrate a risk to drinking water consumers.

Over the last decade, numerous molecular and genetic-based technologies have been developed to detect microorganisms such as flow cytometry, magnetic separation techniques, fluorescence in-situ hybridization (FISH), polymerase chain reaction (PCR), reverse transcriptase-PCR (RT-PCR), and microarrays. The genomic sequences of many microorganisms have been identified and stored in databases around the world (e.g., The Institute for Genomic Research, http://www.tigr.orgexit EPA; the National Center for Biotechnology Information’s GenBank http://www.ncbi.nlm.nih.gov/Genbankexit EPA), providing the core information necessary for development of microarrays. In addition, the rapidly evolving field of nanotechnology may provide its own unique approaches for detecting waterborne pathogens.

Specific Research Areas of Interest/Expected Outputs and Outcomes

The goal of this RFA is to develop and evaluate innovative approaches to quantitatively detect microbial pathogens in source waters and drinking water distribution systems. Microorganisms of concern are those that pose a human health risk via drinking water contamination including, but not limited to, those currently regulated and those on the CCL. (Microorganisms for which there are National Primary Drinking Water Regulations can be found at: http://www.epa.gov/safewater/mcl.html#mcls. The CCL lists are referenced in the Background section of this solicitation.) The proposed approaches must (1) quantitatively determine the occurrence of waterborne pathogens; (2) present a protocol for preparing and processing water samples for application of the proposed approach; and (3) where possible, be compared to the approved EPA method. Those pathogens for which EPA has approved detection methods can be found at: http://www.epa.gov/nerlcwww/index.html.

All proposals must:

  • describe how they will evaluate the protocol for preparing and processing water samples for the target pathogens, including but not limited to, necessary concentration steps, especially regarding the percent recovery and the precision of the protocol;
  • include testing of actual field samples (both spiked and unspiked with relevant microorganisms) following validation of the proposed approach against pure cultures;
  • compare and contrast the proposed approach under development with standard water quality methods regarding the sensitivity, specificity, and positive and negative predictive values; and
  • clearly state how the robustness, feasibility, ease of use, availability, applicability, and limitations of the proposed approach will be addressed.

To the extent possible, proposed approaches should attempt to:

  1. Be “rapid” or “near real-time,” i.e., results should be obtainable within minutes or hours, not days.
  2. Determine the viability and/or infectivity of the waterborne pathogen.
  3. Detect and enumerate multiple waterborne pathogens.
  4. Detect and enumerate pathogens occurring at low concentrations in the water.
  5. Distinguish pathogenic from non-pathogenic strains.
  6. Identify the model system to test for pathogenicity.
  7. Determine if any specific microbial gene sequences can be used as diagnostic tools of drinking water quality.

References

Amann RI, Ludwig W and Schleifer KH (1995). Phylogenetic identification and in situ detection of individual cell without cultivation. Microbiol. Rev. 59:143-169.

Craun GF, Nwauchuku N, Calderon RL, and Craun MC. (2002). Outbreaks in Drinking-Water Systems, 1991-1998. Journal of Environmental Health 65:16-23.

Ford, TE. 1999. Microbiological safety of drinking water: United States and global perspectives. Environ Health Perspect 107(Suppl 1):191-206.

Szewzyk, U, Szewzyk R, Manz W, and Schleifer K-H. (2000). Microbiological safety of drinking water. Annu. Rev. Microbiol. 54: 81-127

US Environmental Protection Agency (USEPA). (1998). Announcement of the drinking water contaminant candidate list: Notice. 63 Fed. Reg. 10273 (March 2, 1998). (http://www.epa.gov/fedrgstr/EPA-WATER/1998/March/Day-02/w5313.htm).

US Environmental Protection Agency (USEPA). (2003). Announcement of Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List. 68 Fed. Reg. 42897 (July 18, 2003). (http://www.epa.gov/fedrgstr/EPA-WATER/2003/July/Day-18/w18151.htm).

US Environmental Protection Agency (USEPA). (2003). Drinking Water Research Program Multi-YearPlan. (http://intranet.epa.gov/ospintra/Planning/dw.pdf).

US Environmental Protection Agency (USEPA). (2005). Drinking Water Contaminant Candidate List 2; Final Notice. 70 Fed. Reg. 9071 (February 24,2005).(http://www.epa.gov/fedrgstr/EPA-WATER/2005/February/Day-24/w3527.htm).

Authority and Regulations

The authority for this RFA and resulting awards is contained in the Safe Drinking Water Act, Section 1442, 42 U.S.C. 300j-1 and the Clean Water Act, Section 104, 33 U.S.C.

II. AWARD INFORMATION

It is anticipated that a total of approximately $5 million will be awarded under this announcement, depending on the availability of funds. EPA anticipates funding approximately seven to ten grants under this RFA. The projected award per grant is $100,000 to $200,000 per year total costs, for up to 3 years. Requests for amounts in excess of a total of $600,000, including direct and indirect costs, will not be considered. The total project period for an application submitted in response to this RFA may not exceed three years. EPA reserves the right to reject all applications and make no awards under this RFA. EPA reserves the right to make additional awards under this RFA if additional funding materializes. The additional selections for awards will be made no later than four months after the original selection decisions.

EPA intends to fund grants rather than cooperative agreements under this announcement. Agency scientists will not be substantially involved in the research projects 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

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

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

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

Federal agencies may not apply. Federal employees are not eligible to serve in a principal leadership role on a grant, and may not receive salaries or in other ways augment their agency's appropriations through grants made by this program.

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

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

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

Cost Sharing

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

IV. APPLICATION AND SUBMISSION INFORMATION

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

Internet Address to Request Application Package

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

Content and Form of Application Submission

The initial application is made through submission of the materials described below. It is essential that the application contain all information requested and be submitted in the formats described. Noncompliance with formatting instructions (page limits, font size, etc.) will result in the application being rejected without further review. Please note that if an application is being considered for an award (i.e., after external peer review and internal review), additional forms and other information will be requested by the EPA Project Officer. The initial application must contain the following:

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

“Intergovernmental Review of Federal Programs.” If so, an applicant should consult the office or official designated as the single point of contact in his or her state for more information on the process the state requires to be followed in applying for assistance, if the state has selected the program for review. Additional information regarding E.O. 12372 may be found at http://www.whitehouse.gov/ombgrants/spoc.htmlexit EPA.

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

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

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

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

1. Research Category and Sorting Code: Enter the full name of the solicitation under which your application is submitted and the code that corresponds to the appropriate RFA topic.

2. Title: Use the exact title of your project as it appears in the application. The title must be brief, yet represent the major thrust of the project. Because the title will be used by those not familiar with the project, strike a balance between highly technical words and phrases and more commonly understood terminology. Do not use phrases such as “research on.”

3. Investigators: List the Principal Investigator, then the names and affiliations of each co-investigator who will significantly contribute to the project. Provide a web site URL or an E-Mail contact address for additional information.

4. Institution: In the same order as the list of investigators, list the name and city/state of each participating university or other applicant institution. The institution applying for assistance must be clearly identified.

5. Project Period: Show the proposed project beginning and ending dates.

6. Project Cost: Show the total dollar request, including direct and indirect costs, to the EPA for all grant years (the entire project period).

7. Project Summary: Provide three subsections addressing: (a) the objectives of the study (including any hypotheses that will be tested), (b) the experimental approach to be used (a description of the project proposed ), and (c) the expected results of the project and how it addresses the research needs identified in the solicitation, including the estimated improvement in risk assessment or risk management that will result from successful completion of the proposed work.

8. Supplemental Keywords: Supply keywords to assist database searchers in finding your research, without duplicating terms already used in the text of the abstract. A complete set of keywords is very important. A list of suggested keywords will be found at http://www.epa.gov/ncer/rfa/forms/

E. Research Plan and Quality Assurance Statement

Research Plan (15 pages)

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

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

1. Objectives: List the objectives of the proposed research and the hypotheses being tested during the project, and briefly state why the intended research is important. This section should also include any background or introductory information that would help explain the objectives of the study. If this application is for continuation of research supported by an existing or former grant awarded under the STAR program, indicate the number of the grant and provide a brief report of progress and results achieved under that grant (one to two pages recommended).

2. Approach/ Activities/Outputs: Outline the research design, methods, and techniques that you intend to use in meeting the objectives stated above (five to 10 pages recommended).

3. Expected Results, Benefits and Outcomes: Describe the results you expect to achieve during the project and the benefits of the results. This section should also discuss how the research results will lead to solutions to environmental problems and improve the public’s ability to protect the environment and human health. A clear, concise description will help NCER understand the merits of the research (one to two pages recommended) .

4. General Project Information: Discuss other information relevant to the potential success of the project. This should include facilities, personnel, project schedules, proposed management, interactions with other institutions, etc. Applications for multi-investigator projects must identify project management and the functions of each investigator within a team and describe plans for communication and sharing of data (one to two pages recommended).

5. Important Attachments:
References cited are in addition to the 15-page Research Plan limit.

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

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

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

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

1. Identify the individual who will be responsible for the quality assurance and quality control aspects of the research. [Quality assurance (QA) is an integrated system of management activities involving planning, implementation, documentation, assessment, and improvement to ensure that a process, or item is of the type and quality needed for the project. Quality control (QC) is the system of technical activities that measures the attributes and performance of a process or item against defined standards, to verify that they meet the stated requirements.]

2. Discuss the activities to be performed or the hypothesis to be tested and criteria for determining acceptable data quality. (Note: Such criteria may be expressed in terms of precision, accuracy, representativeness, completeness, and comparability or in terms of data quality objectives or acceptance and evaluation criteria.) Also, these criteria must be applied to determine the acceptability of existing, or “secondary,” data to be used in the project. (In this context, secondary data may be defined as data previously collected for other purposes or from other sources.)

3. Describe the study design. Include sample type(s) and location requirements, all statistical analyses that were or will be used to estimate the types and numbers of physical samples required, or equivalent information for studies using survey and interview techniques, or describe how new technology will be benchmarked to improve existing processes, such as those used by industry.

4. Describe the procedures that will be used in the calibration and performance evaluation of all analytical instrumentation and all methods of analysis to be used during the project. Explain how the effectiveness of any new technology will be measured.

5. Describe the procedures for the handling and custody of samples, including sample collection, identification, preservation, transportation, and storage, or how the accuracy of test measurements will be verified.

6. Discuss the procedures for data reduction and reporting, including a description of all statistical methods to make inferences and conclusions, with identification of any statistical software to be used; discuss any computer models to be designed or utilized and describe the associated verification and validation techniques.

7. Describe the quantitative and/or qualitative procedures that will be used to evaluate the success of the project, including any plans for peer or other reviews of the study design or analytical methods prior to data collection.

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

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

F. Budget and Budget Justification

Budget

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

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

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

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

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

1. Personnel: List all staff positions by title. Give annual salary, percentage of time assigned to the project, and total cost for the budget period.

2. Fringe Benefits: Identify the percentage used and the basis for its computation.

3. Travel: Specify the estimated number of trips and locations, and other costs for each type of travel. Explain the need for any travel outside the United States. Include travel funds for annual STAR program progress reviews and a final workshop to report on results.

4. Equipment: Identify computers, and all other tangible non-expendable personal property to be purchased which 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).

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 costs: If indirect costs are included in the budget, indicate the approved rate and base with an explanation of how indirect costs were calculated.

G. Resumes and Current and Pending Support

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

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

H. Guidelines, Limitations, and Additional Requirements
Confidentiality

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

In accordance with 40 CFR 2.203, applicants may claim all or a portion of their application/proposal as confidential business information. EPA will evaluate confidentiality claims in accordance with 40 CFR Part 2. Applicants must clearly mark applications/proposals or portions of applications/proposals they claimasconfidential.If no claim of confidentiality is made, EPA is not required to make the inquiry to the applicant otherwise required by 40 CFR 2.204(c)(2) prior to disclosure.

Sorting Codes

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

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

Data Policy

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

Letters of Intent/Letters of Support

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

Submission Instructions for Electronic Applications

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 the CFDA number of 66.509 or Funding Opportunity Number 2005-STAR-K1. Be sure to download the electronic application package for the appropriate sorting code/topic area. 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). Please see http://www.grants.gov/exit EPA , “Get Started” for further information. The registration process may take a week or longer. Please check with your Sponsored Programs or equivalent office to locate your 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. Please 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.

A. Application for Federal Assistance (SF-424)

  1. Complete the form. There are no attachments.

B. EPA Key Contacts Form 5700-54

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

C. Project Narrative Attachment Form

  1. Compile the Research Plan 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.”

D. 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.
    a. Label your Budget document Budget and submit it as the “Add Mandatory Budget Narrative.”
    b. Label the Budget Justification document BudgetJustification and submit it as an “Add Optional Budget Narrative” document.
  3. When submitting letters of intent, first refer to the “Letters of Intent/Letters of Support” paragraph under Section 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.

E. 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.

Please close all other software before attempting to submit the application package. If you experience submission problems, please reboot your computer (turning the power off may be necessary) and re-attempt the submission. If you continue to experience submission problems, 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: 202-564-1790, Email: harrison.bronda@epa.gov).

Submission Dates and Times

For paper copy submissions, the original and two (2) copies of the complete application (3 in all) and one (1) additional copy of the abstract (for a total of 4), must be received by NCER no later than 4:00 p.m. Eastern Time on the solicitation closing date identified below; electronic applications must be transferred to http://www.grants.gov/exit EPA no later than 4:00 p.m. Eastern Time on the solicitation closing date identified below. The following is the anticipated schedule for this RFA. It should be noted that this schedule may be changed without prior notification due to factors that were not anticipated at the time of announcement. In the case of a change in the required receipt date, a new date will be posted on the NCER web site (http://www.epa.gov/ncer/).

Solicitation Closing Date: June 9, 2005, 4:00 p.m. E.T.
Earliest Anticipated Start Date: January 2006

To be considered timely, paper copy applications and initial proposals must be received by NCER on or before the solicitation closing date published above; electronic submissions must be transferred to http://www.grants.gov/exit EPA on or before the solicitation closing date published above. Applications received after the published deadline date, or applications that are not submitted in compliance with the application submission instructions and requirements described above, will be returned to the sender without further consideration. Also, applications exceeding the funding limits described in the RFA will be returned without review.

Funding Restrictions

The funding mechanism for all awards issued under STAR solicitations will consist of assistance agreements from the EPA. All award decisions are subject to the availability of funds. In accordance with 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 Agency. In issuing a grant agreement, the EPA anticipates that there will be no substantial EPA involvement in the design, implementation, or conduct of the research. However, the EPA will monitor research progress through annual reports provided by grantees and other contacts, including site visits, with the Principal Investigator.

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

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

Other Submission Requirements (This section is not relevant when submitting electronically.)

The application and abstract must be prepared in accordance with these instructions. Informal, incomplete, or unsigned applications will be returned without review. The original, signed copy of the application must not be bound or stapled in any way. The other two (2) required copies of the application should be secured with paper or binder clips or secure staples.

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

The following address must be used for regular mail:

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

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

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

V. APPLICATION REVIEW INFORMATION

Criteria

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

1. a. The originality and creativity of the proposed research, the appropriateness and adequacy of the research methods proposed, and of the Quality Assurance Statement.
b. Is the research approach practical and technically defensible, and can the project be performed within the proposed time period?
c. Will the research contribute to scientific knowledge in the topic area?
d. What are the projected benefits of the proposed activity to society such as improvements to the environment or human health?
e. Will the results be disseminated broadly to enhance scientific and technological understanding?
f. Is the proposal well-prepared with supportive information that is self-explanatory or understandable?

2. The qualifications of the principal investigator(s) and other key personnel, including research training, demonstrated knowledge of pertinent literature, experience, and publication records. Will all key personnel make a significant time commitment to the project?

3. The responsiveness of the proposal to the research needs identified for the topic area. Does the proposal adequately address the objectives specified by the EPA for this topic area?

4. The availability and/or adequacy of the facilities and equipment proposed for the project. Are there any deficiencies that may interfere with the successful completion of the research?

5. Although budget information does not reflect on the application’s scientific merit, the reviewers are asked to provide their view on the appropriateness and/or adequacy of the proposed budget and its implications for the potential success of the proposed research. Input on requested equipment is of particular interest.

Review and Selection Process

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

For those applications receiving scores of excellent and very good as a result of the peer review, a programmatic review is then conducted by technical experts from within EPA, including ORD and program and Regional offices involved with the science or engineering proposed. The programmatic review considers the relevance of the proposed science to EPA research priorities, program balance, budget, available funds, and considerations such as support for the congressionally mandated Experimental Program to Stimulate Competitive Research (EPSCOR): http://www.epa.gov/ncer/other/. The purpose of the programmatic review is to assure a balanced research portfolio for the Agency and determine which applications to recommend for award. Final funding decisions are made by the NCER Director based on the results of the programmatic review. Applicants who are selected for funding will be required to provide additional information and the application will be forwarded to the grants administration office for award in accordance with the EPA’s procedures.

Anticipated Announcement and Award Dates

The following is the anticipated 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: June 9, 2005
Earliest Anticipated Start Date: January 2006

VI. AWARD ADMINISTRATION INFORMATION

Award Notices

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

Administrative and National Policy Requirements

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

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

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

C. Human Subjects: A grant recipient must agree to meet all EPA requirements for studies using human subjects prior to implementing any work with these subjects. These requirements are given in 40 C.F.R. 26, referred to as the “Common Rule.” No work involving human subjects, including recruiting, may be initiated before the EPA has received a copy of the applicant’s Institutional Review Board’s (IRB) approval of the project and the EPA has also provided approval. Where human subjects are involved in the research, the recipient must provide evidence of subsequent IRB reviews, including amendments or minor changes of protocol, as part of annual reports.

D. Animal Welfare: A grant recipient must agree to comply with the Animal Welfare Act of 1966 (P.L. 89-544), as amended, 7 USC 2131-2156. The recipient must also agree to abide by the “U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training.” (50 Federal Register 20864-20865. May 20,1985)

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

F. Disputes: Assistance agreement competition-related disputes will be resolved in accordance with the dispute resolution procedures set forth in 70 FR 3629, 3630 (January 26, 2005) which can be found at, http://www.epa.gov/ogd/competition/resolution.htm. Copies of these procedures may also be requested by contacting Cynthia Nolt-Helms; Phone: 703-347-8102; Email: nolt-helms.cynthia@epa.gov or Angela D. Page; Phone 703-347-8046; Email: page.angelad@epa.gov.

Reporting

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

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

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

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

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

VII. AGENCY CONTACTS

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

Technical Contacts: Cynthia Nolt-Helms; Phone: 703-347-8102; Email: nolt-helms.cynthia@epa.gov or Angela D. Page; Phone 703-347-8046; Email: page.angelad@epa.gov

Eligibility Contact: Tom Barnwell; Phone 202-343-9862, Email: barnwell.thomas@epa.gov

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

Do not attempt to seek information regarding this RFA from any source other that those contacts identified above as the information provided may not be accurate.

Agency policy prohibits EPA laboratory scientists from providing applicants for competitive grants with information that would provide them with an unfair advantage. Consequently, EPA laboratory scientists will not review, comment, provide technical assistance or other advice on applications to EPA RFAs, or discuss how the Agency will apply the published evaluation criteria for this competition.

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