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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

Fate and Effects of Hormones in Waste From Concentrated Animal Feeding Operations (CAFOS)

This is the initial announcement of this funding opportunity.

Funding Opportunity Number: EPA-G2006-STAR-M1

Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: May 8, 2006
Solicitation Closing Date: August 9, 2006, 4:00 p.m. Eastern 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 Contact: Susan Laessig, phone: 202-343-9617; email: (laessig.susan@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
Introduction
Background
Authority and Regulations
Specific Areas of Interest/Expected Outputs and Outcomes
References
Special Requirements
II. AWARD INFORMATION
III. ELIGIBILITY INFORMATION
Eligible Applicants
Cost Sharing
Other
IV. APPLICATION AND SUBMISSION INFORMATION
Internet Address to Request Application Package
Content and Form of Application Submission
Submission Dates and Times
Funding Restrictions
Other Submission Requirements
V. APPLICATION REVIEW INFORMATION
Criteria
Review and Selection Process
VI. AWARD ADMINISTRATION INFORMATION
Award Notices
Disputes
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 to characterize the occurrence, magnitude, and extent of the impact of natural and synthetic steroid hormones in liquid and solid animal waste from concentrated animal feeding operations (CAFOs) on the environment and human health. This program also provides support for research to determine the impact of current CAFO waste management strategies (i.e. storage and disposal) on the transport, fate, and effects of steroid hormones originating from CAFOs.

CAFOs represent a potential concentrated source of natural and synthetic steroid hormones that could contaminate the environment by seepage into surface and groundwater and runoff from field applications of animal waste. Information is limited on the transport, fate, potential exposures, and subsequent effects associated with steroid hormones, especially estrogens, androgens, and progestins used primarily to enhance animal production, from different types of CAFOs and different waste management strategies. This is an area of potential concern, because these operations are becoming more prevalent in many regions of the U.S.

This RFA solicits research in the following areas:

The results of this research will contribute to improving estimates of the occurrence and risks of steroid hormones associated with animal waste and developing new or improved animal waste handling systems and risk management options for steroid hormones in animal waste.

Award Information:
Anticipated Type of Award: Grants or Cooperative Agreements
Estimated Number of Awards: Approximately 3 awards
Anticipated Funding Amount: Approximately $2.1 million total for all awards
Potential Funding per Grant or Cooperative Agreement: Up to a total of $700,000, including direct and indirect costs, with a duration not to exceed 3 years. Cost-sharing is not required.
Proposals with budgets exceeding $700,000 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 for submitting a STAR application will be found on the National Center for Environmental Research (NCER) web site, http://www.epa.gov/ncer/rfa/forms/. To apply electronically, you must use the application package available at https://apply.grants.gov/forms_apps_idx.html exit EPA (see "Submission Instructions for Electronic Applications" in Section IV). If your organization is not currently registered with grants.gov, you need to allow approximately one week to complete the registration process to apply electronically. This registration, and electronic submission of your application, must be performed by an appropriate 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 Contact: Susan Laessig, phone: 202-343-9617; email: (laessig.susan@epa.gov)

I. FUNDING OPPORTUNITY DESCRIPTION

Introduction
Preventing and controlling water pollution from large-scale animal feeding operations is a major priority for EPA. The U.S. Environmental Protection Agency's (EPA) Office of Water (OW) regulates pollutant discharges from concentrated animal feeding operations (CAFOs) under authority of the Clean Water Act. In order to protect human health and the environment, the Clean Water Act gives OW the authority to regulate pollutants, including nutrients, sediment, and chemicals, that can be discharged into U.S. waters from CAFOs. An "animal feeding operation" (AFO) is defined (40 CFR 122.23) as a lot or facility where animals have been, are, or will be stabled or confined and fed or maintained for a total of 45 days or more in any 12 month period and where crops, vegetation forage growth, or post-harvest residues are not sustained in the normal growing season over any portion of the lot or facility. The animal livestock industry is diverse and includes a number of different types of animals such as cattle, swine, poultry, and others that are kept and raised in confined situations. A CAFO is an AFO that either exceeds a size threshold (number of animals confined), exhibits certain water discharge characteristics, or is designated by a regulatory official as contributing significantly to the pollution of surface waters (see definitions in CAFO Final Rule, http://cfpub.epa.gov/npdes/afo/cafofinalrule.cfm).

Because of the volume of animal waste generated, CAFOs can pose a number of potential risks to the environment and public health. Storage and disposal or use of liquid and solid waste from CAFOs must adequately control for nutrient release (e.g., nitrogen, phosphorus). CAFOs should also control for organic matter, sediments, pathogens, heavy metals, hormones, antibiotics, and ammonia that are released in order to protect the environment and health of surrounding communities. Steroid hormones in animal waste from CAFOs are currently being studied by researchers in EPA's Office of Research and Development (ORD) as part of the Endocrine Disruptors Research Program as described in the Endocrine Disruptors Research Plan (USEPA, 1998) and the Multi-Year Plan for Endocrine Disruptors (USEPA, 2003a). Competitive Science to Achieve Results (STAR) grants are being solicited to complement the research being conducted by EPA's intramural laboratories.

The ORD Multi-Year Plan (MYP) for Endocrine Disruptors describes three Long-Term Goals.

  1. Provide a better understanding of the science underlying the effects, exposure, assessment, and management of endocrine disruptors. Research includes determining: dose-response relationships, effects of exposure to multiple endocrine disrupting chemicals (EDCs), and approaches for assessing and managing risks.
  2. Determine the extent of the impact of endocrine disruptors on humans, wildlife, and the environment. Research includes determining how and to what degree human and wildlife populations are exposed to EDCs, what effects are occurring in exposed human and wildlife populations, and what are the major sources of exposure and environmental fates.
  3. Support EPA’s screening and testing program for EDCs. Research includes determining whether testing guidelines adequately evaluate potential endocrine-mediated effects.

This request for applications (RFA) addresses key areas of ORD’s EDC MYP Long Term Goals 1 and 2 described above in order to develop the fundamental science and characterize the occurrence, magnitude, and extent of the impact of steroid hormones in animal waste from CAFOs. In addition, the research program seeks to describe the impact of current CAFO animal waste management strategies on the fate and effects of natural and synthetic steroid hormones in the environment. The predicted outcomes of the research are an improved understanding of the risks associated with steroid hormones in animal waste and the development of new or improved animal waste handling systems and risk management options for steroid hormones in animal waste.

Background
Nationally, there are an estimated 1.3 million farms holding livestock in the U.S. About 238,000 of these farms are considered animal feeding operations (AFOs) where animals are held and raised in confinement. AFOs generate more than 500 million tons of animal waste annually and can pose substantial risks to the environment and public health (USEPA, 2003b). The trend in agriculture is toward CAFOs that confine a large number of animals in a small area and that, compared to smaller operations, have limited land available for effective use of the generated waste as fertilizer. Currently, very little is known about occurrence, fate and transport, and environmental effects resulting from exposures to natural and synthetic steroid hormones in animal waste from CAFOs that may be discharged into the environment.

There is a potential for natural and synthetic steroid hormones (e.g. estrogens, androgens, progestins) found in CAFO waste to reach groundwater aquifers and surface waters through a multitude of pathways (e.g. surface runoff, leaching from holding tanks and lagoons and composting facilities). However, information on releases, fate, and transport of estrogens, androgens, and progestins originating from CAFOs is minimal. The occurrence of hormonally-active agents in surface water is of increasing concern worldwide, and has led to a growing awareness that human and wildlife health might be negatively impacted by hormones in the environment (National Research Council, 1999). The U.S. Geological Survey recently conducted an extensive survey of U.S. streams potentially impacted by pharmaceuticals, hormones, and other organic wastewater contaminants (Kolpin et al., 2002). About one third of the water contaminants detected in this survey are known or suspected to exhibit hormonal activity and can lead to disruption of normal endocrine function (Orlando et al., 2004; Miller and Ankley, 2004). All hormonally-active agents analyzed were found in at least one surface water sample. Even less well-understood is the movement of hormones from CAFO wastes into groundwater aquifers. While land application of CAFO wastes can often be managed to preclude surface water impacts, the movement of hormones in the top soil and vadose zone is not well known, so the potential impact of hormones from CAFO wastes on groundwater is therefore of great concern.

Both natural and synthetic steroids and their metabolites are released in animal waste and have been detected in runoff from CAFOs (Schiffer et al., 2001; Lange et al., 2002). Estrogen, androgens, and progestin agonistic and antagonistic activities have been associated with CAFO effluents (Durhan et al., 2005; Soto et al., 2004) and female fish downstream from CAFOs have been masculinized (Orlando et al., 2004). Growth-promoting steroid hormones that are currently approved by the U.S. Food and Drug Administration (FDA) for use in cattle include estrogens (e.g. estradiol and zeranol), androgens (e.g. testosterone and trenbolone acetate), and progestins (e.g. progesterone and melengesterol acetate). Synthetic steroid hormones and their metabolites have been detected in significant concentrations in cattle waste and found to be persistent in the soil (Schiffer et al., 2001). Currently, federal regulations do not allow synthetic steroid hormone treatment in other livestock such as poultry or swine (21CFR522). However, male and female sex hormones (i.e. estradiol, testosterone, and progesterone) are produced naturally in mammals and birds, especially during pregnancy and are found in large quantities in animal waste from CAFOs (Lange et al., 2002).

The hormones that are present in animal wastes can enter the environment through direct discharge, spills, or leaching from holding tanks, animal confinement areas, waste handling, and containment systems, or through surface runoff from agricultural land where waste is applied as fertilizer. Runoff from fields with land-applied poultry litter has been reported to contain estrogens, testosterone, and progesterone (Finlay-Moore et al., 2000). There is little information on the release of estrogens from swine operations, although estrogen activity can be measured in storage lagoons (Fine et al., 2003).

Moreover, the real-world exposures associated with CAFOs in surface waters, groundwater, and sediment and the resulting impact of these steroid hormones on aquatic and terrestrial organisms and humans is largely unknown. Potential concerns from the environmental contamination of steroid hormones include effects on reproductive and developmental processes including neurological and immunological impairment in mammalian and non-mammalian species. Both acute and chronic effects of environmental exposure to steroid hormones and their metabolites are of concern because these compounds are not readily degraded, and therefore persist and remain biologically active for a long period of time. Even at relatively low environmental levels, they have been shown to have effects on aquatic organisms. For example, trenbolone has been shown to be a potent reproductive toxicant in fathead minnows (Ankley et al., 2003) and has adversely affected wild fathead minnow populations below a cattle feedlot (Orlando et al., 2004). The specific EPA Strategic Goal, Objective and Sub-objective that relates to this solicitation includes: Goal 4: Healthy Communities and Ecosystems, Objective: 4.5 Enhance Science and Research, Sub-objective: 4.5.2 Conduct Relevant Research. EPA’s Strategic Plan can be found on the following web page: http://www.epa.gov/ocfo/plan/2003sp.pdf. (PDF, 239pp., 4.75MB, about PDF)

Authority and Regulations
The authority for this RFA and resulting awards is contained in the Clean Water Act, Section 104, 33 U.S.C., Safe Drinking Water Act, Section 1442, 42 U.S.C. 300j-1, and Solid Waste Disposal Act, Section 8001, 42 U.S.C. 6901.

Specific Research Areas of Interest/Expected Outputs and Outcomes
Note to applicant: The term "output" means an environmental activity or effort, and associated work products, related to a specific environmental goal(s), (such as producing a new methodology), that will be produced or developed over a period of time under the agreement. The term "outcome" means the result, effect, or consequence that will occur from the above activit(ies) that is related to an environmental, behavioral, or health-related objective.

The U.S. Environmental Protection Agency (EPA), as part of its Science to Achieve Results (STAR) program, is seeking applications proposing to characterize the occurrence, magnitude, and extent of the impact of natural and synthetic steroid hormones (i.e. estrogens, androgens and progestins) in liquid and solid animal waste from CAFOs and determine the impact of current CAFO waste management strategies (i.e. storage and disposal) on the fate and effects of steroid hormones.

This RFA solicits proposals that would address one or more of the following areas of interest:

Proposed research may aim to characterize the occurrence and concentrations of estrogens, androgens, progestins, and respective metabolites in animal waste from CAFOs housing animals of different livestock species, ages, genders, and/or feeding regimens. Projects could also examine the environmental fate in soil and/or water of steroids and their metabolites from stored and land applied wastes or investigate the stability of synthetic steroid hormones in soil and/or aquatic environments. Of interest is how different waste management practices (e.g. aerial spraying, ground injection) alter the stability and availability of steroid hormones in the environment. In addition, projects may choose to examine regional differences and seasonal variability of steroid hormones originating from CAFO animal waste.

Additional considerations:

The expected outputs of the solicitation will include research papers, reports, and publications to help improve the understanding of the underlying science, characterize the magnitude and extent of the impact of CAFOs as environmental sources of steroid hormones, and determine the impact of current CAFO waste management strategies on the fate and effects of steroid hormones in the environment. The predicted outcomes of the research are an improved understanding of the risk associated with steroid hormones in animal waste and the development of new or improved animal waste handling systems and risk management options for steroid hormones in animal waste.

References

Ankley GT, Jensen KM, Makynen EA, Kahl MD, Korte JJ, Hornung MW, Henry TR, Denny JS, Leino RL, Wilson VS, Cardon MC, Hartig PC, Gray LE. 2003. Effects of the androgenic growth promoter 17-beta-trenbolone on fecundity and reproductive endocrinology of the fathead minnow. Environ Toxicol Chem. 22(6):1350-1360.

Durhan EJ, Lambright CS, Makynen EA, Lazorchak J, Hartig PC, Wilson VS, Gray LE and Ankley GT. 2005. Identification of Metabolites of Trenbolone Acetate in Androgenic Runoff from a Beef Feedlot. Environ, Health Perspect,: doi:10.1289/ehp.8055. [Online 21 October 2005]

Fine DD, Breidenbach GP, Price TL, Hutchins SR. 2003. Quantitation of estrogens in ground water and swine lagoon samples using solid-phase extraction, pentafluorobenzyl/trimethylsilyl derivatizations and gas chromatography-negative ion chemical ionization tandem mass spectrometry. J, Chromatogr, A. 1017(1-2):167-185.

Finlay-Moore, O., P.G. Hartel, and M.L. Cabrera. 2000. 17-estradiol and testosterone in soil and runoff from grasslands amended with broiler litter. J. Environ. Qual. 29:1604-1611.

Kolpin, D.W., E.T. Furlong, M.T. Meyer, E.M. Thurman, S.D. Zaugg, L.B. Barber, and H.T. Buxton. 2002. Pharmaceuticals, hormones, and other organic wastewater contaminants in U.S. streams, 1999- 2000: A national reconnaissance. Environ. Sci. Technol. 36:1202-1211.

Lange I.G., A. Daxenberger, B. Schiffer, H. Witters, D. Ibarreta, and H.H. Meyer. 2002. Sex hormones originating from different livestock production systems: fate and potential disrupting activity in the environment. Anal. Chim. Acta. 473:27-37.

Miller D.H. and G.T. Ankley. 2004. Modeling impacts on populations: fathead minnow (Pimephales promelas) exposure to the endocrine disruptor 17-trenbolone as a case study. Ecotoxicol. Environ. Saf. 59(1):1-9.

Orlando E.F., A.S. Kolok, G.A. Binzcik, J.L. Gates, M.K. Horton, C.S. Lambright, L.E. Gray Jr, A.M. Soto, and L.J. Guillette Jr. 2004. Endocrine-disrupting effects of cattle feedlot effluent on an aquatic sentinel species, the fathead minnow. Environ. Health Perspect. 112(3):353-8.

National Research Council. 1999. Hormonally Active Agents in the Environment. National Academy Press: Washington, DC.

Schiffer, B., A. Daxenberger, K. Meyer, and H.D. Meyer. 2001. The fate of trenbolone acetate and melengestrol acetate after application as growth promoters in cattle: Environmental Studies. Environ. Health Persp. 109(11):1145-1151.

Soto, A.M., J.M. Calabro, N.V. Prechtl, A.Y. Yau, E.F. Orlando, A. Daxenberger, A.S. Kolok, L.J. Guillette, B. le Bizec, I.G. Lange, and C. Sonnenschein. 2004. Androgenic and estrogenic activity in water bodies receiving cattle feedlot effluent in eastern Nebraska, USA. Environ. Health Perspect. 112:346-352.

US Environmental Protection Agency (USEPA). 1996. Strategic plan for the Office of Research and Development. Washington, DC, EPA/600R-96-059 (http://www.epa.gov/osp/strtplan/documents/final.pdf). (PDF, 48pp., 4.65MB, about PDF)

US Environmental Protection Agency (USEPA). 1998. ORD's Endocrine Disruptors Research Plan (http://www.epa.gov/ord/htm/documents/ORD-EDR-Feb1998.pdf). (PDF, 56pp., 648KB, about PDF)

US Environmental Protection Agency (USEPA). 2003a. Multi-Year Plan for Endocrine Disruptors (http://www.epa.gov/osp/myp/edc.pdf). (PDF, 79pp., 417KB, about PDF)

US Environmental Protection Agency (USEPA). 2003b. NPDES Permit Writers' Guidance Manual and Example NPDES Permit for Concentrated Animal Feeding Operations, EPA-833-B-04-001.

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

Groups of two or more eligible applicants may choose to form a consortium and submit a single application for this assistance agreement. The application must identify which organization will be the recipient of the assistance agreement and which organizations(s) will be subawardees of the recipient.

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 a grant 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.

II. AWARD INFORMATION

It is anticipated that a total of approximately $2.1 million will be awarded under this announcement, depending on the availability of funds.  The EPA anticipates funding approximately 3 grants or cooperative agreements under this RFA.  Requests for amounts in excess of a total of $700,000, 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 3 years.  The EPA reserves the right to reject all applications and make no awards 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 will either fund grants or cooperative agreements under this RFA. 

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

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

III. ELIGIBILITY INFORMATION

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 grants 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 grant from the EPA to an FFRDC for research personnel, supplies, equipment, and other expenses directly related to the research.  However, salaries for permanent FFRDC employees may not be provided through this mechanism.

Federal Agencies may not apply.  Federal employees are not eligible to serve in a principal leadership role on a grant, and may not receive salaries or augment their Agency’s appropriations in other ways through grants made by 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)

Cost-Sharing
Institutional cost-sharing is not required.

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 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.

Studies on ecological exposures and effects are required to include a field component and must investigate realistic environmental concentrations of natural and/or synthetic steroid hormones and their metabolites in discharges and wastes from CAFOs to be considered for funding.

To be considered for funding, a proposed project must consist of activities within the statutory terms of EPA’s grant authorities.  Most of the statutes authorize grants for the following activities: “research, investigations, experiments, training, demonstrations, surveys and studies.” 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 relate to the gathering or transferring of information or advancing the state of knowledge. Grant proposals should emphasize this “learning” concept, as opposed to “fixing” an environmental problem via a well-established method.  In light of this, 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.

IV. APPLICATION AND SUBMISSION INFORMATION

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

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

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

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

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

  1. Standard Form 424

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

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

  2. Key Contacts

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

  3. Table of Contents

    4. 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.)

  4. Abstract (1 page)

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

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

    1. Research Category and Funding Opportunity Number: The appropriate research area(s) and associated number(s) for this RFA are: Fate and Effects of Hormones in Waste from Concentrated Animal Feeding Operations (CAFOs), Endocrine Disruptors; Funding Opportunity Number: EPA-G2006-STAR-M1.
    2. Title: Use the exact title of your project as it appears in the application.  The title must be brief yet represent the major thrust of the project.  Because the title will be used by those not familiar with the project, strike a balance between highly technical words and phrases and more commonly understood terminology.  Do not use general phrases such as “research on.”
    3. Investigators: List the Principal Investigator, then the names and affiliations of each co-investigator who will significantly contribute to the project.  Provide a web site URL or an email contact address for additional information.
    4. Institution: In the same order as the list of investigators, list the name, city and state of each participating university or other applicant institution.  The institution applying for assistance must be clearly identified.
    5. Project Period: Show the proposed project beginning and ending dates.
    6. Project Cost: Show the total dollars requested from the EPA (include direct and indirect costs for all grant years).
    7. Project Summary: Provide three subsections addressing: (a) the objectives of the study (including any hypotheses that will be tested), (b) the experimental approach to be used (a description of the project proposed), and (c) the expected results of the project and how it addresses the research needs identified in the solicitation, including the estimated improvement in risk assessment or risk management that will result from successful completion of the proposed work.
    8. Supplemental Keywords: Without duplicating terms already used in the text of the abstract, list keywords to assist database searchers in finding your research.  A list of suggested keywords can be found at:http://www.epa.gov/ncer/rfa/forms.

  5. Research Plan and Quality Assurance Statement

    6. 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 grant awarded under the STAR program, indicate the number of the grant and provide a brief report of progress and results achieved under that grant (one to two pages recommended).
    2. Approach/Activities: Outline the research design, methods, and techniques that you intend to use in meeting the objectives stated above (five to ten pages recommended).
    3. Expected Results, Benefits, Outputs, and Outcomes: Describe the results you expect to achieve during the project (outputs) and the benefits of the results (outcomes). This section should also discuss how the research results will lead to solutions to environmental problems and improve the public's ability to protect the environment and human health. A clear, concise description will help NCER understand the merits of the research (one to two pages recommended).
    4. General Project Information: Discuss other information relevant to the potential success of the project. This should include facilities, personnel expertise/experience, project schedules, proposed management, interactions with other institutions, etc. Applications for multi-investigator projects must identify project management and the functions of each investigator in each team and describe plans to communicate and share data (one to two pages recommended).
    5. Appendices may be included but must remain within the 15-page limit.

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

    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.

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

  6. Budget and Budget Justification

    7. 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 grant will be subject to special review.  Additional justification for use of such subcontracts must be provided, discussing the need for this agreement to accomplish the objectives of the research project.

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

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

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

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

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

  7. Resumes and Current and Pending Support

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

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

  8. Guidelines, Limitations, and Additional Requirements

    9. Confidentiality

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

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

    Funding Opportunity Number

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

    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.

Submission Dates and Times

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

Solicitation Closing Date Date: August 9, 2006, 4:00 pm Eastern Time
Earliest Anticipated Start Date: January 2007

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 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 grant 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.

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

Submission Instructions for Paper Applications

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

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

The following address must be used for regular mail:

U.S. Environmental Protection Agency
Peer Review Division (8725F)
Funding opportunity number: EPA-G2006-STAR-M1
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-M1
1025 F Street, NW (Room 3500)
Washington , DC 20004
Phone: (202) 233-0686

Submission Instructions for Electronic Applications Using Grants.gov

The electronic application package available through the http://www.grants.gov/ exit EPA web site must be used for electronic submissions. In order to view the application package, download the PureEdge viewer (hyperlink available under "Apply for Grants" then "Apply Step 1"). The application package may be quickly accessed from https://apply.grants.gov/forms_apps_idx.html exit EPA using either the CFDA number of 66.509 or the Funding Opportunity Number: EPA-G2006-STAR-M1. Be sure to download the electronic application package for the appropriate funding opportunity number or topic. It is recommended that you “Register to Receive Notification” of announcement updates.

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

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

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

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

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

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

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

V. APPLICATION REVIEW INFORMATION

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.

Review and Selection Process
All grant applications are reviewed by an appropriate external technical peer review panel using the criteria above. 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 proficient in the technical subjects they are reviewing. Reviewers are asked to assign a summary score of excellent, very good, good, fair, or poor to each application. This review is designed to evaluate each application according to its scientific merit.

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 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 is permitted for the response; pages in excess of three will not be reviewed. Note: If no prior past performance information exists, please state this.

  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, 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).

The internal programmatic review panel will consider:

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

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

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 can bind the Government to the expenditure of funds; preliminary selection by the NCER Director in the Office of Research and Development does not guarantee an award will be made. Before or after an award, applicants may be required to provide additional quality assurance documentation.

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.

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

  1. Meetings: Principal Investigators will be expected to budget for, and participate in, All-Investigators Meetings (also known as progress reviews) 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 nonspecialists alike to be able to understand how and where the data were obtained and to evaluate the quality of the data. If requested, the data products and their metadata must be provided to the 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.

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

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

  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.

    7. 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 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.

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

VII. AGENCY CONTACTS

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

Eligibility Contact: Tom Barnwell: 202-343-9862; email: (barnwell.thomas@epa.gov)
Electronic Submissions: Bronda Harrison: 202-343-9777; email: (harrison.bronda@epa.gov)
Technical Contact: Susan Laessig, phone: 202-343-9617; email: (laessig.susan@epa.gov)

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