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Funding Opportunities

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

CLOSED - FOR REFERENCES PURPOSES ONLY

Sources, Composition, and Health Effects of Coarse Particulate Matter

This is the initial announcement of this funding opportunity.

Funding Opportunity Number: EPA-G2006-STAR-Q1
Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: July 21, 2006
Solicitation Extended Closing Date: November 30, 2006, 4:00 pm Eastern Standard Time

Eligibility Contact: Tom Barnwell: 202-343-9862; email: (barnwell.thomas@epa.gov)
Electronic Submissions: Bronda Harrison: 202-343-9777; email: (harrison.bronda@epa.gov)
Technical Contacts: Barbara Glenn; phone: 202-343-9721; email: (glenn.barbara@epa.gov)
Darrell Winner; phone: 202-343-9748; email: (winner.darrell@epa.gov)

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

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

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 studies of thoracic coarse particulate matter (PM10-2.5); its sources, composition, variability and health effects.

Award Information:
Anticipated Type of Award: Grant
Estimated Number of Awards: Approximately 5 awards
Anticipated Funding Amount: Approximately $5 million total for all awards
Potential Funding per Grant: Up to $1,200,000 per project including direct and indirect costs with a maximum duration of 4 years. Cost-sharing is not required. Proposals with budgets exceeding the total award limits will not be considered.

Eligibility Information:
Public nonprofit institutions/organizations (includes public institutions of higher education and hospitals) and private nonprofit institutions/organizations (includes private institutions of higher education and hospitals) located in the U.S.; state and local governments; Federally Recognized Indian Tribal Governments; and U.S. territories or possessions are eligible to apply. See full announcement for more details.

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

Contact Persons:
Eligibility Contact: Tom Barnwell: 202-343-9862; email: (barnwell.thomas@epa.gov)
Electronic Submissions: Bronda Harrison: 202-343-9777; email: (harrison.bronda@epa.gov)
Technical Contacts: Barbara Glenn; phone: 202-343-9721; email: (glenn.barbara@epa.gov)
Darrell Winner; phone: 202-343-9748; email: (winner.darrell@epa.gov)

I. FUNDING OPPORTUNITY DESCRIPTION

A. Introduction

The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications proposing studies of PM10-2.5 evaluating potential health effects, sources, composition, and variability. PM10-2.5 represents the subset of coarse particles that is inhaled into the lungs and penetrates into the thoracic region. Sources of PM10-2.5 include construction and demolition activities, mining and mineral processing, agricultural activities, sea spray, wind-blown dust, and resuspension of settled biological material from soil surfaces and roads (EPA, 2005a; EPA, 2004). Information regarding the heterogeneity, composition, and sources of PM10-2.5 characteristic of specific locations and comparisons between locations, especially rural versus urban areas, that inform studies of health effects is needed.

The objectives of this RFA are to:

• Improve understanding of the type and severity of health outcomes associated with PM10-2.5.
• Improve understanding of subpopulations that may be especially sensitive to PM10-2.5 exposures including minority populations (e.g., Native Americans, Hispanics, African Americans), highly exposed groups, and other susceptible groups.
• Characterize and compare the influence of mass, composition, source characteristics and exposure estimates in different locations on differences in health outcomes, including comparisons of rural and urban areas.
• Characterize the composition and variability of PM10-2.5 in towns, cities or metropolitan areas, including comparisons of rural and urban areas.

B. Background

Coarse thoracic particles are composed of predominately crustal-related materials such as calcium, aluminum, silicon, magnesium, and iron, and primary organic materials such as pollen, spores, and plant and animal debris (EPA, 2005a; EPA, 2004). Some components, such as nitrate and potassium, are common to both PM10-2.5 and PM2.5, although the source or formation processes are different. The ambient relative humidity in a region can affect how much particle-bound water is present and this can act as a conveyor of dissolved gases or reactive species in the lungs. Particle bound water may also alter the size distribution of particles, thereby affecting particle deposition characteristics. These characteristics, combined with a different pattern of deposition in the lung, support the assumption that PM10-2.5 and PM2.5 may have different biologic effects, toxicity, and potency.

A nationwide network of PM10-2.5 monitors is not currently in place, though PM10-2.5 concentration data are available from a number of sources. Some epidemiology studies have used PM10 and PM2.5 concentrations to develop estimates of PM10-2.5 exposure and associations with health endpoints. The EPA and the States have maintained a national network to measure and collect PM10 concentrations since 1987 and, after establishment of the PM2.5 standard, a network was set up to measure PM2.5 concentrations beginning in 1999. Over 90 percent of the PM2.5 monitors are located in urban areas. There is also an Interagency Monitoring to Protect Visual Environments (IMPROVE) monitoring network for PM2.5 located in national parks and wilderness areas throughout the U.S., although the instruments and measurement protocols are not identical to the urban network (see http://vista.cira.colostate.edu/improve/). The monitoring data for PM10 and PM2.5 can be used to estimate PM10-2.5 over a larger portion of the U.S. than was previously possible. For example, in a recent EPA analysis of estimated PM10-2.5 concentrations in the U.S. between 2001 and 2003, data were compiled from monitors in 351 counties. The data are not complete for all quarters at all locations, however (EPA 2005b) (see http://www.epa.gov/oar/oaqps/pm25/2005analyses.html). Research studies may not be able to rely solely on the PM10-2.5 monitoring data collected by the networks described above to accomplish the goals of this RFA and may need to supplement the data to produce valid exposure estimates.

The EPA may begin to support a national monitoring network for PM10-2.5 if the Agency’s proposed revisions to the standards for PM are finalized. Once established, these data also will be available to health researchers. On January 17, 2006, EPA also announced proposed revisions to the national air quality monitoring system that included the development of a national monitoring network for PM10-2.5 (for more information see http://www.epa.gov/ttnamti1/files/ambient/pm25/frnoticejan2006.pdf) (PDF, 100pp., 2.52MB, about PDF). (EPA 2006b). The proposed network of approximately 250 monitoring sites will preferably utilize Federal Equivalent Method (FEM) semi-continuous (hourly) PM10-2.5 methods and a smaller number of federal reference method (FRM) samplers that involve subtracting a filter-based PM2.5 measurement from a PM10 measurement. If this revision is adopted, the Agency anticipates that the FRM/FEM network would be deployed by January 1, 2009. Also, a limited number of between 50 and 100 of the PM10-2.5 sites are proposed to have speciation to assess physical and chemical characteristics of the coarse particles.

While many epidemiology studies have reported associations of mortality and morbidity with ambient PM2.5 or PM10, fewer studies have evaluated associations with PM10-2.5 (Brunekreef and Forsberg 2005). Overall, the epidemiology studies indicate that short-term exposure to ambient PM10-2.5 is associated with increased mortality risk and hospital admissions, primarily due to cardiovascular and respiratory effects (EPA 2004; EPA 2005a). Very little data are available concerning long-term exposure to PM10-2.5; however, no link to morbidity or mortality has been indicated. The published studies investigating PM10-2.5 are limited in number and are restricted to a small number of locations, the findings are inconsistent, and they do not address effects of different components or sources of PM10-2.5 particles. In addition, it is difficult to interpret the findings of some of the studies because risk estimates may be influenced by measurement error in exposure estimates.

The body of evidence concerning PM10-2.5 exposure and clinical measurements in humans or animals is small. PM10-2.5 exposure is linked to alterations in cardiac function in humans (Gong et al. 2004; Lipsett et al. 2006). Like PM2.5, evidence from in vitro and animal studies is accumulating indicating that PM10-2.5 from road dust or collected urban particles, and rural particles (but not volcanic ash), may cause an inflammatory response, oxidant stress to cells, cytotoxicity or have allergic adjuvant activity (Schins et al. 2004; Steerenberg et al. 2005; Steerenberg et al. 2006; Becker et al. 2005b; Shi et al. 2003). While several personal characteristics, including current health status, or population attributes appear to result in greater vulnerability to the effects of PM exposure in general, no data are available to identify those factors that confer unique susceptibility to PM10-2.5. Few studies have compared the toxicity of PM10-2.5 characteristic of rural and urban areas. Further, few studies have compared the toxicity of PM collected from significant sources including dust from roads, agricultural fields, mining activities, construction sites or other significant sources of coarse thoracic PM.

The EPA currently supports a number of air pollution-related research grants resulting from previous solicitations. Information regarding current research can be found on ORD’s National Center for Environmental Research (NCER) web site at http://www.epa.gov/ncer/.

The specific Strategic Goal, Objective and Sub-objective from EPA's Strategic Plan that relate to this solicitation include:

Goal 1: Clean Air and Global Climate Change, Objective 1.6: Enhance Science and Research, Sub-objective 1.6.2: Conduct Air Pollution Research

The EPA's Strategic Plan can be found at http://www.epa.gov/ocfo/plan/2003sp.pdf (PDF, 239pp., 4.75MB, about PDF).

C. Authority and Regulations

The authority for this RFA and resulting awards is contained in the Clean Air Act, Section 103, 42 U.S.C. 7403.

Specific Research Areas of Interest/Expected Outputs and Outcomes

This RFA solicits applications that must address one or more of the following key questions:

1. Are coarse particles found in rural and in urban areas associated with adverse health effects? Does the type of health outcome and the magnitude of estimated risk differ between rural and urban areas?
2. Are there specific subpopulations that are more sensitive to PM10-2.5 exposures? If so, what are the characteristics of these subpopulations? The understanding of coarse particle effects in minority populations (e.g., native Americans, African Americans, and Hispanics) is of special interest.
3. What factors influence the variability of PM10-2.5 mass and composition between locations (including rural & urban differences)? How does PM10-2.5 vary seasonally and daily on these same spatial scales?
4. How do source and compositional differences of PM10-2.5 affect the type and severity of health outcomes? How do these differences affect who is susceptible to adverse health outcomes? What is the impact of exposure measurement error on effect estimates?

Interdisciplinary studies are strongly encouraged. We are particularly interested in studies designed to jointly address pressing scientific issues concerning health effects of PM10-2.5 and susceptibility, sources and composition. We are interested in studies that compare PM10-2.5 from rural and urban areas, and thoracic coarse PM from specific sources including roads, agricultural fields, mining activities, and other sources. Studies designed to compare the relative toxicity of PM10-2.5 in different geographic locations may include epidemiological, clinical, or toxicological approaches. Air quality studies to measure the spatial variability of PM10-2.5 concentrations and composition should be designed to inform epidemiological study designs and analyses. Epidemiologists should consider how to best obtain high quality air quality data to support their analyses. Note that if a national air monitoring network for PM10-2.5 is developed, EPA will consider the data needs of health studies when the Agency develops recommendations to State and local governments concerning the siting of monitors.

Studies are needed that aim to reduce uncertainty in exposure estimates used by population and panel studies. Studies that characterize the spatial and temporal heterogeneity of PM10-2.5 within a study area as well as composition and sources of PM10-2.5 would contribute to understanding and comparing risk estimates developed for different locations. Exposure estimates based on ambient outdoor PM10-2.5 concentrations in a community may not adequately reflect personal exposure to ambient PM10-2.5. Health studies may want to address the relationship between ambient concentration and personal exposure to ambient PM10-2.5 to reduce the uncertainty in exposure estimates.

Several outputs will be developed from the research supported from this solicitation. Expected outputs include reports, presentations, and articles in peer-reviewed journals summarizing data and analyses that will identify important sources of ambient coarse thoracic PM that contribute to population exposure in different geographic locations, characterize spatial and temporal variability of PM10-2.5 mass and components and their relative influence on health effect estimates, and identify characteristics that confer greater susceptibility to impacts on health. The outputs will contribute to important outcomes including reduced uncertainty in health risk assessments, and increased efficiency in federal and state/local air quality management strategies that target the most significant sources and components and most susceptible populations.

E. References

Becker S, Dailey LA, Soukup JM, Grambow SC, Devlin RB, Huang YC (2005) Seasonal variations in air pollution particle-induced inflammatory mediator release and oxidative stress. Environ Health Perspect 113:1032-1038.

Brunekreef B, Forsberg B. (2005) Epidemiological evidence of effects of coarse airborne particles on health. Eur Respir J 26:309-318.

Burnett R, Goldberg MS. (2003) Size fractionated particulate mass and daily mortality in 8 Canadian cities. In: Health Effects Institute, Special Report. Revised analyses of time-series studies of air pollution and health. pp. 85-89.

Burnett RT, Brook J, Dann T, et al. (2000) Association between particulate- and gas-phase components of urban air pollution and daily mortality in eight Canadian cities. Inhal Toxicol 12:Suppl. 4: 15-39.

Environmental Protection Agency. (2004) Air Quality Criteria for Particulate Matter. Research Triangle Park, NC: Office of Research and Development; report no. EPA/600/P-99/002a,bF. October.

Environmental Protection Agency. (2005a). Review of the National Ambient Air Quality Standards for Particulate Matter: Policy Assessment of Scientific and Technical Information (OAQPS Staff Paper). Research Triangle Park, NC: Office of Air Quality Planning and Standards; report no. EPA-452/R-05-005a. December.

Environmental Protection Agency (2005b). Memorandum from Mark Schmidt, OAQPS, David Mintz, OAQPS, Tesh Rao, OAQPS, and Lance McCluney, OAQPS, dated January 31, 2005 regarding Draft Analyses of Particulate Matter (PM) Data for the PM NAAQS Review. Available at: http://www.epa.gov/oar/oaqps/pm25/2005analyses.html.

Environmental Protection Agency (2006a) National Ambient Air Quality Standards for Particulate Matter: Proposed Rule 40 CFR Part 50 71 Federal Register 2620 January 16, 2006. Available at: http://epa.gov/air/particles/actions.html.

Environmental Protection Agency (2006b) Revisions to Ambient Air Monitoring Regulations: Proposed Rule; amendments. 40 CFR Parts 50 and 58. 71 Federal Register 2710 January 17, 2006. Available at: http://www.epa.gov/ttnamti1/files/ambient/pm25/frnoticejan2006.pdf (PDF, 100pp., 2.52MB, about PDF).

Gong H, Linn WS, Terrell SL, Clark KW, Geller MD, Anderson KR, Cascio WE, Sioutas C (2004). Altered heart-rate variability in asthmatic and healthy volunteers exposed to concentrated ambient coarse particles. Inhal Toxicol 16:335-343.

Klemm RJ, Mason RM Jr, Heilig CM, Neas LM, Dockery DW. (2000) Is daily mortality associated specifically with fine particles? Data reconstruction and replication of analyses. J Air Waste Manag Assoc 50:1215-1222.

Schwartz J, Dockery DW, Neas LM. (1996) Is daily mortality associated specifically with fine particles? J Air Waste Manag Assoc 46:927-939.

Schins RP, Lightbody JH, Borm PJ, Shi T, Donaldson K, Stone V (2004). Inflammatory effects of coarse and fine particulate matter in relation to chemical and biological constituents. Toxicol App. Pharmacol 195:1-11.

Shi T, Knaapen AM, Begerow J, Birmili W, Borm PJ, Schins RP (2003). Temporal variation of hydroxyl radical generation and 8-hydroxy-2'-deoxyguanosine formation by coarse and fine particulate matter. Occup Environ Med. 60:315-21.

Steerenberg PA, Withagen CE, van Dalen WJ, Dormans JA, Heisterkamp SH, van Loveren H, Cassee FR (2005). Dose dependency of adjuvant activity of particulate matter from five European sites in three seasons in an ovalbumin-mouse model. Inhal Toxicol 17:133-145.

Steerenberg PA, van Amelsvoort L, Lovik M, Hetland RB, Alberg T, Halatek T, Bloemen HJ, Rydzynski K, Swaen G, Schwarze PE, Dybing E, Cassee RF (2006) Relation between sources of particulate air pollution and biological effect parameters in samples from four European cities: an exploratory study. Inhal Toxicol 18:333-346.

F. Special Requirements

Agency policy prevents EPA technical staff and managers from providing individual applicants information that may create an unfair competitive advantage. Consequently, EPA employees will not review, comment, advise, provide technical assistance to applicants preparing applications in response to EPA RFAs, endorse an application or discuss in any manner how the Agency will apply the published evaluation criteria for this competition.

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

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

II. AWARD INFORMATION

It is anticipated that a total of approximately $5 million will be awarded under this announcement, depending on the availability of funds and quality of applications received. The EPA anticipates funding approximately 5 grants under this RFA. Requests for amounts in excess of a total of $1,200,000 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 4 years. The EPA reserves the right to reject all applications and make no awards, or make fewer awards than anticipated, under this RFA. The EPA reserves the right, consistent with agency policy and without further competition, to make additional awards under this RFA if additional funding becomes available. Any additional selections for awards will be made no later than 4 months after the original selection decisions.

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

III. ELIGIBILITY INFORMATION

A. Eligible Applicants

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

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

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

Federal Agencies may not apply. Federal employees are not eligible to serve in a principal leadership role on a assistance agreement, and may not receive salaries or augment their Agency's appropriations in other ways through awards made under this program.

The applicant institution may enter into an agreement with a Federal Agency to purchase or utilize unique supplies or services unavailable in the private sector. Examples are purchase of satellite data, census data tapes, chemical reference standards, analyses, or use of instrumentation or other facilities not available elsewhere. A written justification for federal involvement must be included in the application. In addition, an appropriate form of assurance that documents the commitment, such as a letter of intent from the Federal Agency involved, should be included.

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

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

C. Other

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

Research supported under this solicitation must address one or more of the research topics listed in Section I Part D. Proposals that do not address at least one of these specific research topics will not be funded.

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

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

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 types of submission follow. If not otherwise marked, instructions apply to both types of submissions.

A. Internet Address to Request Application Package

For paper applications, forms, formats, and instructions can be found on the NCER web site: http://www.epa.gov/ncer/rfa/forms/.

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

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

B. Content and Form of Application Submission

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

1. Standard Form 424

   The applicant must complete form SF424. This form will be the first page(s) of the application. Instructions for completion of the SF424 are included with the form. (However, note that EPA requires that the entire requested dollar amount appear on the 424, not simply the proposed first year expenses.) The form must contain the original (or electronic) signature of an authorized representative of the applying institution. Please note that both the Principal Investigator and an administrative contact must be identified on the SF424.

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

   Executive Order 12372, "Intergovernmental Review of Federal Programs," applies to most EPA programs and assistance agreements, unless the program or assistance agreement supports tribal, training/fellowships (other than Wastewater and Small Water Systems Operator training programs), and research and development (with some exceptions). The SF424 refers to this Executive Order requirement. National research programs are generally exempt from review unless the proposals: (a) require an Environmental Impact Statement (EIS); or (b) do not require an EIS but will be newly initiated at a particular site and require unusual measures to limit the possibility of adverse exposure or hazard to the general public; or (c) have a unique geographic focus and are directly relevant to the governmental responsibilities of a State or local government within that geographic area. To determine whether their state participates in this process, and how to comply, applicants should consult http://www.whitehouse.gov/omb/grants/spoc.html .

2. Key Contacts

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

3. Table of Contents

   Provide a list of the major subdivisions of the application indicating the page number on which each section begins. (Not required for electronic submissions.)

4. Abstract (1 page)

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

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

   1. Research Category and Funding Opportunity Numbers: The appropriate research areas and associated numbers for this RFA are:
      Sources, Composition, and Health Effects of Coarse Particulate Matter, EPA-G2006-STAR-Q1
   2. Title: Use the exact title of your project as it appears in the application. The title must be brief yet represent the major thrust of the project. Because the title will be used by those not familiar with the project, strike a balance between highly technical words and phrases and more commonly understood terminology. Do not use general phrases such as "research on."
   3. Investigators: List the Principal Investigator, then the names and affiliations of each co-investigator who will significantly contribute to the project. Provide a web site URL or an email contact address for additional information.
   4. Institution: In the same order as the list of investigators, list the name, city and state of each participating university or other applicant institution. The institution applying for assistance must be clearly identified.
   5. Project Period: Show the proposed project beginning and ending dates.
   6. Project Cost: Show the total dollars requested from the EPA (include direct and indirect costs for all years).
   7. Project Summary: Provide three subsections addressing: (a) the objectives of the study (including any hypotheses that will be tested), (b) the experimental approach to be used (a description of the project proposed), and (c) the expected results of the project and how it addresses the research needs identified in the solicitation, including the estimated improvement in risk assessment or risk management that will result from successful completion of the proposed work.
   8. Supplemental Keywords: Without duplicating terms already used in the text of the abstract, list keywords to assist database searchers in finding your research. A list of suggested keywords can be found at: http://www.epa.gov/ncer/rfa/forms.


5. Research Plan and Quality Assurance Statement


1. Research Plan (15 pages)

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

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

   The description must provide the following information:

1. Objectives: List the objectives of the proposed research and the hypotheses being tested during the project, and briefly state why the intended research is important and how it fulfills the requirements of the solicitation. Describe the policy, planning and/or decision-making that the research is intended to inform. This section should also include any background or introductory information that would help explain the objectives of the study. If this application is to continue research supported by an existing or former assistance agreement awarded under the STAR program, indicate the number of the agreement and provide a brief report of progress and results achieved under it (one to two pages recommended).
2. Approach/Activities: Outline the research design, methods, and techniques that you intend to use in meeting the objectives stated above (five to ten pages recommended).
3. Expected Results, Benefits, Outputs, and Outcomes: Describe the results you expect to achieve during the project (outputs) and the potential benefits of the results (outcomes). This section should also discuss how the research results will lead to solutions to environmental problems and improve the public’s ability to protect the environment and human health. A clear, concise description will help NCER understand the merits of the research (one to two pages recommended).
4. General Project Information: Discuss other information relevant to the potential success of the project. This should include facilities, personnel expertise/experience, project schedules, proposed management, interactions with other institutions, etc. Applications for multi-investigator projects must identify project management and the functions of each investigator in each team and describe plans to communicate and share data (one to two pages recommended).
5. Appendices may be included but must remain within the 15-page limit.



2. Quality Assurance Statement (1 to 3 pages in addition to the 15-page research plan)

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

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

1. Identify the individual who will be responsible for the quality assurance (QA) and quality control (QC) aspects of the research along with a brief description of this person's functions, experience, and authority within the research organization. Describe the organization's general approach for conducting quality research. (QA is a system of management activities to ensure that a process or item is of the type and quality needed for the project. QC is a system of activities that measures the attributes and performance of a process or item against the standards defined in the project documentation to verify that they meet those stated requirements.)
2. Discuss project objectives, including quality objectives, any hypotheses to be tested, and the quantitative and/or qualitative procedures that will be used to evaluate the success of the project. Include any plans for peer or other reviews of the study design or analytical methods.
3. Address each of the following project elements as applicable:
   1. Collection of new/primary data:
      (Note: In this case the word "sample" is intended to mean any finite part of a statistical population whose properties are studied to gain information about the whole. If certain attributes listed below do not apply to the type of samples to be used in your research, simply explain why those attributes are not applicable.)
   1. Discuss the plan for sample collection and analysis. As applicable, include sample type(s), frequency, locations, sample sizes, sampling procedures, and the criteria for determining acceptable data quality (e.g., precision, accuracy, representativeness, completeness, comparability, or data quality objectives).
   2. Describe the procedures for the handling and custody of samples including sample collection, identification, preservation, transportation, and storage, and how the accuracy of test measurements will be verified.
   3. Describe or reference each analytical method to be used, any QA or QC checks or procedures with the associated acceptance criteria, and any procedures that will be used in the calibration and performance evaluation of the analytical instrumentation.
   4. Discuss the procedures for overall data reduction, analysis, and reporting. Include a description of all statistical methods to make inferences and conclusions, acceptable error rates and/or power, and any statistical software to be used.
   2. Use of existing/secondary data (i.e., data previously collected for other purposes or from other sources):
      1. Describe or reference each analytical method to be used, any QA or QC checks or procedures with the associated acceptance criteria, and any procedures that will be used in the calibration and performance evaluation of the analytical instrumentation.
      2. Discuss the procedures for overall data reduction, analysis, and reporting. Include a description of all statistical methods to make inferences and conclusions, acceptable error rates and/or power, and any statistical software to be used.
   3. Method development:
      (Note: The data collected for use in method development or evaluation should be described in the QAS as per the guidance in section 3A and/or 3B above.)

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

   4. Development or refinement of models:
      (Note: The data collected for use in the development or refinement of models should be described in the QAS as per the guidance in section 3A and/or 3B above.)
      1. Discuss the scope and purpose of the model, key assumptions to be made during development/refinement, requirements for code development, and how the model will be documented.
      2. Discuss verification techniques to ensure the source code implements the model correctly.
      3. Discuss validation techniques to determine that the model (assumptions and algorithms) captures the essential phenomena with adequate fidelity.
      4. Discuss plans for long-term maintenance of the model and associated data.
   5. Development or operation of environmental technology:
      (Note: The data collected for use in the development or evaluation of the technology should be described in the QAS as per the guidance in section 3A and/or 3B above.)
      1. Describe the overall purpose and anticipated impact of the technology.
      2. Describe the technical and quality specifications of each technology component or process that is to be designed, fabricated, constructed, and/or operated.
      3. Discuss the procedure to be used for documenting and controlling design changes.
      4. Discuss the procedure to be used for documenting the acceptability of processes and components, and discuss how the technology will be benchmarked and its effectiveness determined.
      5. Discuss the documentation requirements for operating instructions/guides for maintenance and use of the system(s) and/or process(s).
   6. Conducting surveys:
      (Note: The data to be collected in the survey and any supporting data should be described in the QAS as per the guidance in section 3A and/or 3B above.)

      Discuss the justification for the size of the proposed sample for both the overall project and all subsamples for specific treatments or tests. Identify and explain the rational for the proposed statistical techniques (e.g., evaluation of statistical power).

4. Discuss data management activities (e.g., record-keeping procedures, data-handling procedures, and the approach used for data storage and retrieval on electronic media). Include any required computer hardware and software and address any specific performance requirements for the hardware/software configuration used.

   Page allowances for the following section(s) are in addition to those allowed for the Research Plan and Quality Assurance Statement.

3. Data Plan (2 pages in addition to the 15-page research plan)

   The application must include a plan to make available all data (including primary and secondary/existing data) from observations, analyses, or model development collected or used under an agreement awarded as a result of this RFA in a format and with documentation/metadata such that they may be used by others in the scientific community. Applicants who plan to develop or enhance databases containing proprietary or restricted information must provide a strategy, within the two pages, to make the data widely available, while protecting privacy or property rights.

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


6. Budget and Budget Justification
   1. Budget

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

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

   2. Budget Justification (2 pages in addition to the Section 5 page limitations)

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

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

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

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

8. Current and Pending Support

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

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

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

      All letters that do not commit a resource vital to success of the proposal are considered letters of support. Letters of support, and letters of intent that exceed one brief paragraph, are considered part of the Research Plan and are included in the 15-page Research Plan limit.

      Note: Letters of intent or support must be part of the application; letters submitted separately will not be accepted.

   2. Funding Opportunity Number (FON)

      At various places in the application, applicants are asked to identify the FON. The Funding Opportunity Number for this RFA is: EPA-G2006-STAR-Q1, Sources, Composition, and Health Effects of Coarse Particulate Matter

   3. Confidentiality

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

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

C. Submission Dates and Times

For paper copy submissions, the original and two (2) copies of the complete application (3 in all, see below), and one (1) additional copy of the abstract, must be received by NCER no later than 4:00 pm Eastern Time on the solicitation closing date. Electronic applications must be transferred to Grants.gov no later than 4:00 pm Eastern Time on the solicitation closing date.

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

Applications received after the closing date will be returned to the sender without further consideration.

Solicitation Closing Date: November 30, 2006, 4:00 pm Eastern Time
Earliest Anticipated Start Date: June 2007

D. Funding Restrictions

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

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

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

Any contracts for services or products funded with EPA financial assistance must be awarded under the competitive procurement procedures of 40 CFR Part 30 and/or Part 31. Moreover, naming a specific contractor in the application does not relieve the applicant of its obligations to comply with competitive procurement requirements. Also, the regulations contain limitations on consultant compensation.

E. Submission Instructions and Other Submission Requirements

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

1. Submission Instructions for Paper Applications

   Three (3) copies of the application must be submitted: 1) an original, signed copy; 2) a single-sided copy on plain white paper for scanning (please label this copy); and 3) another photocopy for administrative purposes. What about the additional abstract? Do not permanently bind or staple any of these copies; please use either binder or paper clips to secure them.

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

   The following address must be used for regular mail:

   U.S. Environmental Protection Agency
   Peer Review Division (8725F)
   Funding opportunity number: EPA-G2006-STAR-Q1
   1200 Pennsylvania Avenue, NW
   Washington, DC 20460

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

   U.S. Environmental Protection Agency
   Peer Review Division (8725F)
   Funding opportunity number: EPA-G2006-STAR-Q1
   1025 F Street, NW (Room 3500)
   Washington, DC 20004
   Phone: (202) 233-0686

2. Submission Instructions for Electronic Applications

   Please read this entire section before attempting an electronic submission through Grants.gov.

   1. Preparing for Submission. The appropriate electronic application package available through the http://www.grants.gov 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 using the appropriate Funding Opportunity Number. Be sure to download the electronic application package for the appropriate Funding Opportunity Number. "Register to Receive Notification" in order to receive automatic notification of announcement updates.

      The electronic submission of your application package must be made by an official representative of your institution who is registered with Grants.gov and authorized to sign for Federal assistance.  For more information, go to http://www.grants.gov and click on “Get Registered” on the left side of the page. Note that the registration process may take a week or longer to complete.  If your organization is not currently registered with Grants.gov, please encourage your office to designate an AOR and begin the registration process as soon as possible.  Most submission problems can be avoided by communicating with the AOR well before the solicitation closing date and allowing sufficient time for following the guidance provided below should submission problems be experienced.

   2. Acknowledgement of Receipt. The complete application must be transferred to Grants.gov no later than 4:00 pm Eastern Time on the solicitation closing date (see “Submission Dates and Times”). Grants.gov provides acknowledgements of application receipt that include an on-screen notification of successful initial transfer as well as an e-mail notification of successful transfer from Grants.gov to EPA. While it is advisable to retain copies of these Grants.gov acknowledgements to document submission, the only official documentation that the application has been received by NCER is the e-mail acknowledgement sent by NCER to the Principal Investigator and the Administrative Contact. This email will be sent from receipt.application@epa.gov; email to this address will not be accepted. If an email acknowledgment from NCER (not support@grants.gov) has not been received within 30 days of the solicitation closing date, immediately send an e-mail to Harrison.Bronda@EPA.gov for instructions on how to proceed. Failure to do so may result in your application not being reviewed.
   3. Form of Application. The application package consists of 1 though 4 (below). Item 4 must be submitted in one Adobe Acrobat PDF file. Please review the file for conversion errors prior to including it in the electronic application package; requests to rectify conversion errors will not be accepted if made after the solicitation closing date and time.
      1. On the initial electronic Grant Application Package page, complete the "Application Filing Name" field by entering the Principal Investigator's name, starting with the last name.
      2. Application for Federal Assistance (SF-424): Complete the form.
      3. EPA Key Contacts Form 5700-54: Complete the form. If additional pages are needed, see (4) below.
      4. Add Mandatory Project Narrative, budget, and related information: Attach a single electronic file labeled “Application” that contains the items contained in Section IV.B.4. through IV.B.9.a of this solicitation. If Key Contacts Continuation pages are needed, place them before the Abstract (IV.B.4.). Investigators should save the completed application package with two different file names before providing it to the AOR to avoid having to re-create the package should submission problems be experienced.
      5. Once the application package has been completed, the “Submit” button should be enabled. If the “Submit” button is not active, please contact Grants.gov for assistance (Telephone: 1-800-518-4726).
   4. Transfer of Files.

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

      A successful transfer will end with an on-screen acknowledgement. Print this acknowledgement using “Print Screen” for documentation purposes. If you experience submission problems, reboot the computer – turning the power off may be necessary – and re-attempt the submission. If submission problems continue, contact Grants.gov for assistance (Telephone: 1-800-518-4726).

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

V. APPLICATION REVIEW INFORMATION

A. Overview of Review and Selection Process

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

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

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

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

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

B. Peer Review Criteria

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

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

C. Programmatic Review

The internal programmatic review panel will consider:

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

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

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

VI. AWARD ADMINISTRATION

A. Award Notices

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

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

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

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

B. Disputes

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

C. Administrative and National Policy Requirements

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

1. Meetings: Principal Investigators will be expected to budget for, and participate in, All-Investigators Meetings (also known as progress reviews) approximately once per year with EPA scientists and other grantees to report on research activities and discuss issues of mutual interest.
2. Approval of Changes after Award: Prior written approval is required from the EPA if there will be significant change from work described in the application. Examples of these changes are contained in 40 C.F.R. 30.25. Note: prior written approval is also required from the EPA for incurring costs more than 90 calendar days prior to award.
3. Human Subjects: A grant recipient must agree to meet all EPA requirements for studies using human subjects prior to implementing any work with these subjects. These requirements are given in 40 C.F.R. 26, referred to as the "Common Rule." No work involving human subjects, including recruiting, may be initiated before the EPA has received a copy of the applicant's Institutional Review Board's (IRB) approval of the project and the EPA has also provided approval. Where human subjects are involved in the research, the recipient must provide evidence of subsequent IRB reviews, including amendments or minor changes of protocol, as part of annual reports.
4. Animal Welfare: A grant recipient must agree to comply with the Animal Welfare Act of 1966 (P.L. 89-544), as amended, 7 U.S.C. 2131-2156. The recipient must also agree to abide by the "U.S. Government Principles for the Utilization and Care of Vertebrate Animals used in Testing, Research, and Training" (50 Federal Register 20864-20865. May 20,1985).
5. Data Access and Information Release: After award, all data (including primary and secondary/existing data) must be made available to the NCER Project Officer without restriction and be accompanied by comprehensive metadata documentation adequate for specialists and non-specialists alike to be able to understand how and where the data were obtained and to evaluate the quality of the data. If requested, the data products and their metadata must be provided to the NCER Project Officer in a standard exchange format no later than the due date of the grant's final report or the publication of the data product's associated results, whichever comes first.

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

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

6. 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 posts references to all publications resulting from a grant on the NCER web site.

7. Acknowledgement of EPA Support: EPA's full or partial support must be acknowledged in journal articles, oral or poster presentations, news releases, interviews with reporters and other communications. Any documents developed under this agreement that are intended for distribution to the public or inclusion in a scientific, technical, or other journal shall include the following statement:

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

   A graphic that can be converted to a slide or used in other ways, such as on a poster, is located at http://www.epa.gov/ncer/guidance/star_images.html. EPA expects recipients to use 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. Information regarding this RFA obtained from sources other than these Agency Contacts may not be accurate. Email inquiries are preferred.

Eligibility Contact: Tom Barnwell: 202-343-9862; email: (barnwell.thomas@epa.gov)
Electronic Submissions: Bronda Harrison: 202-343-9777; email: (harrison.bronda@epa.gov)
Technical Contacts: Barbara Glenn; phone: 202-343-9721; email: (glenn.barbara@epa.gov)
Darrell Winner; phone: 202-343-9748; email: (winner.darrell@epa.gov)

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