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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

Development and Use of Adverse Outcome Pathways that Predict Adverse Developmental Neurotoxicity

This is the initial announcement of this funding opportunity.

Funding Opportunity Number: EPA-G2012-STAR-F1

Catalog of Federal Domestic Assistance (CFDA) Number: 66.509

Solicitation Opening Date: September 13, 2012
Solicitation Closing Date: December 12, 2012, 11:59:59 pm Eastern Time

Eligibility Contact: Bronda Harrison (harrison.bronda@epa.gov); phone: 703-347-8080
Electronic Submissions: Todd Peterson (peterson.todd@epa.gov ); phone: 703-308-7224
Technical Contact: Mitch Lasat (lasat.mitch@epa.gov); phone: 703-347-8099

Table of Contents:
SUMMARY OF PROGRAM REQUIREMENTS
	Synopsis of Program
	Award Information
	Eligibility Information
	Application Materials
	Agency Contacts
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. Peer Review
	B. Programmatic Review
	C. Funding Decisions
VI. AWARD ADMINISTRATION INFORMATION
	A. Award Notices
	B. Disputes
	C. Administrative and National Policy Requirements
VII. AGENCY CONTACTS

Access Standard STAR Forms (Forms and Standard Instructions Download Page)
View research awarded under previous solicitations (Funding Opportunities: Archive Page)

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 research that will identify and/or provide a better understanding of adverse outcome pathways (AOPs) that lead to developmental neurotoxicity (DNT).  Such research should advance the state of knowledge by linking key events along the continuum from exposure to adverse outcomes, including windows of susceptibility, and ultimately resulting in AOP-based data and models for chemical testing that will allow risk assessors to predict DNT.  EPA is particularly interested in funding research projects that focus on endocrine signaling pathways that alter neurodevelopment, but will accept research proposals that address other AOPs.

This solicitation does not provide the opportunity for the submission of applications for projects that involve human subjects research. Human subjects research supported by the EPA is governed by EPA Regulation 40 CFR Part 26 (Protection of Human Subjects). Applications proposing human subjects research will not be considered for funding and will be deemed ineligible.

Human subjects research precluded from this Request for Applications (RFA) includes:

Projects that collect data from or about humans which meet the regulatory definition of research with human subjects and are thereby subject to the requirements of EPA Regulation 40 CFR Part 26 and EPA Order 1000.17 Change A1.  This includes projects conducted under programs that are not considered research for other purposes. For example, some demonstration programs and some public health practice programs may include research activities.  Projects that utilize surveys about people or contain identifiable private information also constitutes human subjects research and are not allowable under this solicitation.  All applications must include a Non-Human Subjects Research Determination (as described in Section IV.B.5.c) verifying that the proposed research will not involve human subjects.

Award Information:
Anticipated Type of Award: Grant or cooperative agreement.
Estimated Number of Awards: Approximately five awards.
Anticipated Funding Amount: Approximately $4 million total for all awards.
Potential Funding per Award: Up to a total of $800,000 including direct and indirect costs, with a maximum duration of four 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:
To apply under this solicitation, use the application package available at Grants.gov (for further submission information see Section IV.E. “Submission Instructions and other Submission Requirements”).  The necessary forms for submitting a STAR application will be found on the National Center for Environmental Research (NCER) web site, Forms and Standard Instructions Download Page. If your organization is not currently registered with Grants.gov, you need to allow approximately one week to complete the registration process.  This registration, and electronic submission of your application, must be performed by an authorized representative of your organization.

If you do not have the technical capability to utilize the Grants.gov application submission process for this solicitation, call 1-800-490-9194 or send a webmail message at least 15 calendar days before the submission deadline to assure timely receipt of alternate submission instructions.  In your message  provide the funding opportunity number and title of the program, specify that you are requesting alternate submission instructions, and provide a telephone number, fax number, and an email address, if available.  Alternate instructions will be emailed whenever possible.  Any applications submitted through alternate submission methods must comply with all the provisions of this Request for Applications (RFA), including Section IV, and be received by the solicitation closing date identified above.

Agency Contacts:
Eligibility Contact: Bronda Harrison (harrison.bronda@epa.gov); phone: 703-347-8080
Electronic Submissions: Todd Peterson (peterson.todd@epa.gov ); phone: 703-308-7224
Technical Contact: Mitch Lasat (lasat.mitch@epa.gov); phone: 703-347-8099

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 research that will identify and/or provide a better understanding of key adverse outcome pathways (AOPs) that lead to developmental neurotoxicity (DNT). Such research should advance the state-of-knowledge by linking key events along the continuum from exposure to adverse outcomes, identify windows of susceptibility, and ultimately develop data, methods and models that will allow risk assessors to predict developmental neurotoxicity (DNT). EPA is particularly interested in funding research projects that focus on endocrine signaling pathways that alter neurodevelopment, but will accept research proposals that address other AOPs. EPA is also interested in supporting research that will result in tools and methodologies to facilitate the use of AOPs in the development of more efficient approaches for predicting DNT including screening methods. 

This solicitation seeks to support research that will: 1) develop and apply new data to characterize AOPs for DNT outcomes; 2) advance the state-of-knowledge on the key events that link exposure to adverse DNT outcomes; and 3) develop methodologies, tools, and models for incorporating research results into risk assessments. The EPA currently supports a number of AOP and systems models research grants resulting from previous solicitations.  Information regarding current research can be found on ORD’s National Center for Environmental Research (NCER) web site.

B. Background
B.1. Adverse Outcome Pathways as a Unifying Concept for Predictive Models

A high-priority research area identified by EPA’s Office of Research and Development (ORD) is
the advancement of integrated approaches to develop new prediction techniques including the use of innovative technologies for chemical toxicity testing. Information about EPA’s research program on chemical safety can be found at: Chemical Safety for Sustainability Research. 

Many existing chemicals have not been thoroughly evaluated for potential risks to human health and the environment. Currently there is a need for cost-effective predictive tools and testing methods to generate safety information needed to make better-informed decisions about chemicals. The development of innovative methods that allow for faster and more cost-effective assessment of environmental chemicals will benefit the research and risk assessment communities, including those in academia and industry.

A cornerstone of EPA’s ORD research framework is the use of AOPs to enable the development of effective alternative toxicity testing and risk assessment methods for potentially harmful environmental contaminants Framework for an EPA Chemical Safety for Sustainability Research Program(PDF) (32 pp, 542 K).   AOPs describe the known linkages along the continuum from the molecular initiating event to adverse outcomes in an individual or a population (Sonich-Mullin et al., 2001; Boobis et al., 2008; Ankley et al. 2009).  As such, AOPs outline the sequence of key measurable events, starting an initiating molecular event in which a chemical interacts with a biological target(s); following on through a sequential series of cellular, anatomical and functional changes in biological processes; and ultimately culminating in an adverse outcome of relevance to human or ecological risk assessors (e.g, disrupted neurodevelopment, neurodevelopmental disorders, IQ loss).  Of particular importance for DNT is inclusion of susceptible life-stages and critical windows of exposure during development.  Characterization of AOPs allows for identification of key events for which high-throughput testing methods can be developed. AOPs also provide important information on the development of structure-activity relationships, i.e., using effects information from one chemical (the source chemical) to predict the effect for another structurally similar chemical (the target chemical) (OECD, 2011). Finally, AOPs provide evidence important for qualitative and quantitative predictive models of the adverse outcomes that result from triggering molecular initiating or other key events.

B.2. Adverse Outcome Pathways for Developmental Neurotoxicity in Humans and Other Species

There is a critical need to develop alternative testing methods that allow for more rapid testing of chemicals for DNT potential (Lein et al., 2007; Coecke et al., 2007; Crofton et al., 2011).  While there are a large number of cellular and molecular processes known to be critical to proper development of the nervous system, there are relatively few examples of a comprehensive understanding of a pathway leading from chemical exposure to adverse neurodevelopmental outcomes.  The lack of AOPs hampers the development of alternative testing methods and limits the predictive ability of high-throughput chemical testing. In assessing DNT, additional complexity is added by the developmental stage (or window of susceptibility) at which the organism is exposed to the chemical as well as the biological complexity of the exposed organism or experimental system.  These spatially and temporally dependent dynamic processes in the developing nervous system can result in windows of exposure that pose higher risks for some life stages. Thus, AOPs will need to incorporate and account for neurodevelopmental-stage-relevant key events.

The goal of this RFA is to seek a better understanding of the pathways that link the key events in AOPs from exposure to adverse outcomes.  EPA is particularly interested in funding research projects that focus on endocrine signaling pathways that alter neurodevelopment, but will accept research proposals that address other AOPs. EPA is also interested in tools and methodologies to facilitate the use of AOPs in the development of more efficient screening methods for DNT, and methods for incorporating AOP based screening data in risk assessments. This research will contribute to identifying DNT AOPs for high priority endocrine disruptors, other AOPs critical for DNT, critical exposure routes, and susceptible life stages and populations. This solicitation seeks to support research that will: 1) develop and apply new data to characterize AOPs for DNT outcomes; 2) advance the state-of-knowledge on the key events that link exposure to adverse DNT outcomes; and 3) develop methodologies, tools, and models for incorporating research results into risk assessments.

The specific Strategic Goal and Objective from the EPA’s Strategic Plan that relate to this solicitation are:
Goal 4: Ensuring the Safety of Chemicals and Preventing Pollution, Objective 4.1: Ensure Chemical Safety

More information can be found in EPA’s FY 2011-2015 Strategic Plan

C. Authority and Regulations
The authority for this RFA and resulting awards is contained in the Toxic Substances Control Act, Section 10, 15 U.S.C. 2609, the Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, 7 U.S.C. 136r, the Safe Drinking Water Act, Section 1442, 42 U.S.C. 300j-1, and the Clean Water Act, Section 104, 33 U.S.C. 1254.

For research with an international aspect, the above statutes are supplemented, as appropriate, by the National Environmental Policy Act, Section 102(2)(F).

Note that a project’s focus is to 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 pollution, water pollution, solid/hazardous waste pollution, toxic substances control, or pesticide control depending on which statute(s) is listed above.  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.

Applicable regulations include: 40 CFR Part 30 (Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations), 40 CFR Part 31 (Uniform Administrative Requirements for Grants and Cooperative Agreements to State and Local Governments) and 40 CFR Part 40 (Research and Demonstration Grants).  Applicable OMB Circulars include: OMB Circular A-21 (Cost Principles for Educational Institutions) relocated to 2 CFR Part 220, OMB Circular A-87 (Cost Principles for State, Local and Indian Tribal Governments) relocated to 2 CFR Part 225, and OMB Circular A-122 (Cost Principles for Non-Profit Organizations) relocated to 2 CFR Part 230.

D. 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), (e.g., testing 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 Agency is soliciting research projects that propose innovative approaches to develop AOPs for DNT outcomes. Projects should develop approaches, tools, and models to improve the ability to predict adverse impacts on the developing nervous system from exposure to environmental contaminants.  EPA is particularly interested in proposals that incorporate the following:

1. Characterization of AOPs that provide, at a minimum, qualitative correlative links between molecular initiating events, key events, and adverse neurodevelopmental outcomes. EPA encourages the development of AOPs based on causative links between key events (as per modified Bradford-Hill criteria outlined in Boobis et al. 2008).  
2. Development of AOP-based models that allow for quantitative prediction of adverse outcomes from molecular initiating or other key events. 
3. Development of models that include compensatory mechanisms within the toxicity pathways for the key events are highly encouraged. 
4. Development of assays that provide information on the key events of an AOP for DNT in a manner that allows scaling to high-throughput testing. In this case, high-throughput means the ability to collect concentration- or dose-response data for hundreds of chemicals.
5. Develop a methodology to incorporate the research outputs into risk assessments for developmental neurotoxins.

In developing responsive proposals, the following issues should be discussed in terms of determining whether a hypothetical AOP is relevant:

1. Is the adverse outcome of public health or ecological concern?
2. Is the AOP relevant to the species of concern?
3. What key events may be applicable to the AOP?
4. Are methods available to quantitatively measure the key event(s)?
5. Will the AOP be amenable to predictive modeling for risk assessment?

Examples of research responsive to this RFA may include, but are not limited to, characterization of DNT AOPs that result from:

• activation/initiation of endocrine signaling pathways important to nervous system development,
• alterations in pathways regulating the critical cellular events required for normal nervous system development (e.g., neural differentiation, cell migration, synaptogenesis, neural network formation),
• alterations in pathways that control key neuronal/glial cellular processes that may be particularly sensitive in the developing nervous system, 
• use of innovative methods and models that incorporate multicellular systems or use human cells (e.g., neural stem cells) to build AOPs.

The application should include a discussion of how the proposed research will identify and/or provide a better understanding of key AOPs that lead to developmental neurotoxicity; advance the state-of-knowledge by linking key events along the continuum from exposure to adverse outcomes; identify widows of susceptibility; and lead to the development of models and/or toxicity testing methodologies that predict the potential for a chemical to adversely impact the developing nervous system.  It should also include additional discussion of how these outputs will achieve the goals of faster and more efficient chemical testing, SAR development, or improvement in the reliability of chemical testing to predict adverse effects on humans and other species.

Outputs expected from the research funded under this RFA include reports, presentations, and peer-reviewed journal publications describing advances in the understanding of pathways leading to neurotoxicity, as well as methods and models that allow prediction of temporal and spatial specificity of AOPs, and development of predictive tools and screening methods to evaluate DNT potential in target chemicals. The expected outcome of this research is an increased mechanistic understanding of key events in pathways that lead to DNT.  

The use of innovative approaches to develop AOPs is highly encouraged.  To the extent practicable, research proposals must embody innovation and sustainability.  Innovation for the purposes of this RFA is defined as the process of making changes; a new method, custom or device.  Innovative research can take the form of wholly new applications or applications that build on existing knowledge and approaches for new uses.  Research proposals must include a discussion on how the proposed research is innovative (see Section IV.B.5.a).  The concept of sustainability is based on language in the U.S. National Environmental Policy Act of 1969 (NEPA).  This definition is reiterated in Executive Order 13514, Federal Leadership in Environment, Energy, and Economic Performance, stating that the goal of sustainability is to, “create and maintain conditions, under which humans and nature can exist in productive harmony, that permit fulfilling the social, economic, and other requirements of present and future generations.” Research proposals must include a discussion on how the proposed research will seek sustainable solutions that protect the environment and strengthen our communities (see Section IV.B.5.a).  ORD will draw from all of the above-mentioned innovation and sustainability definitions in the review/evaluation process of recommending research proposals (see Section V.A).

E. References
[Journals]

1. Ankley GT, Bennett RS, Erickson RJ, Hoff DJ, Hornung MW, Johnson RD, Mount DR, Nichols JW, Russom CL, Schmieder PK, Serrrano JA, Tietge JE, Villeneuve DL. Adverse outcome pathways: a conceptual framework to support ecotoxicology research and risk assessment. Environ Toxicol Chem. 2010;29(3):730-41
2. Sonich-Mullin C, Fielder R, Wiltse J, Baetcke K, Dempsey J, Fenner-Crisp P, Grant D, Hartley M, Knaap A, Kroese D, Mangelsdorf I, Meek E, Rice JM, Younes M.  IPCS conceptual framework for evaluating a mode of action for chemical carcinogenesis. Regul Toxicol Pharmacol. 2001 34(2):146-52.
3. Boobis AR, Doe JE, Heinrich-Hirsch B, Meek ME, Munn S, Ruchirawat M, Schlatter J, Seed J, Vickers C. IPCS framework for analyzing the relevance of a noncancer mode of action for humans. Crit Rev Toxicol. 2008;38(2):87-96.
4. Crofton KM, Mundy WR, Lein PJ, Bal-Price A, Coecke S, Seiler AE, Knaut H, Buzanska L, Goldberg A.  Developmental neurotoxicity testing: recommendations for developing alternative methods for the screening and prioritization of chemicals. ALTEX. 2011;28(1):9-15.

[Reports]

1. OECD (2011) Report of the Workshop on Using Mechanistic Information in Forming Chemical Categories Series on Testing and Assessment No. 138, 8-10 December 2010, Crystal City VA, USA.
2. Coecke S, Goldberg AM, Allen S, Buzanska L, Calamandrei G, Crofton KM, Hareng L, Hartung T, Knaut H, Honegger P, Jacobs M, Lein P, Li A, Mundy W, Owen D, Schneider S, Silbergeld E, Reum T, Trnovec T, Monnet-Tschudi F, Bal-Price A.  Workgroup report: incorporating in vitro alternative methods for developmental neurotoxicity into international hazard and risk assessment strategies.  Environ Health Perspect. 2007 115:924-31
3. Lein P, Locke P, Goldberg A. Meeting report: alternatives for developmental neurotoxicity testing. Environ Health Perspect. 2007 115:764-8.
4. US EPA (2011)  Framework for an EPA Chemical Safety for Sustainability Research Program(PDF) (32 pp, 542 K), June 2011, Office of Research and Development, US Environmental Protection Agency
5. Washington, DC.

F. Special Requirements
Agency policy and ethical considerations prevent EPA technical staff and managers from providing applicants with information that may create an unfair competitive advantage.  Consequently, EPA employees will not review, comment, advise, and/or provide technical assistance to applicants preparing applications in response to EPA RFAs.  EPA employees cannot endorse any particular application.

Multiple Investigator applications may be submitted as: (1) a single Lead Principal Investigator (PI) application with Co-PI(s) or (2) a Multiple PI application (with a single Contact PI).  If you choose to submit a Multiple PI application, you must follow the specific instructions provided in Sections IV. and V. of this RFA.  For further information, please see the EPA Implementation Plan for Policy on Multiple Principal Investigators.

This solicitation does not provide the opportunity for the submission of applications for projects that involve human subjects research.  Human subjects research supported by the EPA is governed by EPA Regulation 40 CFR Part 26 (Protection of Human Subjects).   Applications proposing human subjects research will not be considered for funding and will be deemed ineligible.  Human subjects research precluded from this RFA includes projects that collect data from or about humans which meet the regulatory definition of research with human subjects and are thereby subject to the requirements of EPA Regulation 40 CFR Part 26 and EPA Order 1000.17 Change A1.  This includes projects conducted under programs that are not considered research for other purposes. For example, some demonstration programs and some public health practice programs may include research activities. Projects that utilize surveys about people or contain identifiable private information also constitutes human subjects research and are not allowable under this solicitation.  All applications must include a Non-Human Subjects Research Determination (as described in Section IV.B.5.c), verifying that the proposed research will not involve human subjects.

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 shall include a plan (see “Data Plan” in section IV.B.5.d.) to make available to the NCER project officer all data generated (first produced under the award) from observations, analyses, or model development 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.

II. AWARD INFORMATION

It is anticipated that a total of approximately $4 million will be awarded under this announcement, depending on the availability of funds, quality of applications received, and other applicable considerations.  The EPA anticipates funding approximately five awards under this RFA.  Requests for amounts in excess of a total of $800,000, including direct and indirect costs, will not be considered.  The total project period requested in an application submitted for this RFA may not exceed four 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 to make additional awards under this announcement, consistent with Agency policy, if additional funding becomes available after the original selections are made.  Any additional selections for awards will be made no later than six months after the original selection decisions.

EPA may award both grants and cooperative agreements 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.

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 award cooperative agreements under this announcement.  When addressing a research question/problem of common interest, collaborations between EPA scientists and the institution’s 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, the refinement of valuation endpoints, and joint authorship of journal articles on these activities.  Proposals may 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

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, located at 2 CFR Part 230.  However, nonprofit organizations described in Section 501(c) (4) of the Internal Revenue Code that lobby are not eligible to apply.

Foreign governments, international organizations, and non-governmental international organizations/institutions 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 an 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 to the extent authorized by law.  Examples are purchase of satellite data, 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 Bronda Harrison (harrison.bronda@epa.gov) in NCER, phone 703-347-8080.

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 submitted through grants.gov or by other authorized alternate means (see Section IV.E. “Submission Instructions and Other Submission Requirements” for further information) 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.  In addition, applications proposing human subjects research will not be considered for funding and will be deemed ineligible.    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. 

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

IV. APPLICATION AND SUBMISSION INFORMATION

Formal instructions for submission through Grants.gov follow in Section E.

A. Internet Address to Request Application Package
Use the application package available at Grants.gov (see Section E. “Submission Instructions and Other Submission Requirements”).  Note: With the exception of the current and pending support form (available at Forms and Standard Instructions Download Page), all necessary forms are included in the electronic application package.

An email will be sent by NCER to the Lead/Contact PI 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; emails to this address will not be accepted.  If you do not receive an email acknowledgment within 30 days of the submission closing date, immediately inform the Eligibility Contact shown in this solicitation.  Failure to do so may result in your application not being reviewed.  See Section E. “Submission Instructions and Other Submission Requirements” for additional information regarding the application receipt acknowledgment.

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

1. Standard Form 424

   The applicant must complete Standard Form 424. 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 signature of an authorized representative of the applying organization.

   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 D&B web site.

   Executive Order 12372, “Intergovernmental Review of Federal Programs,” does not apply to the Office of Research and Development's research and training programs unless EPA has determined that the activities that will be carried out under the applicants' proposal (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.

   If EPA determines that Executive Order 12372 applies to an applicant's proposal, the applicant must follow the procedures in 40 CFR Part 29. The applicant must notify their state's single point of contact (SPOC). To determine whether their state participates in this process, and how to comply, applicants should consult Intergovernmental Review (SPOC List). If an applicant is in a State that does not have a SPOC, or the State has not selected research and development grants for intergovernmental review, the applicant must notify directly affected State, area wide, regional and local entities of its proposal.

   EPA will notify the successful applicant(s) if Executive Order 12372 applies to its proposal prior to award.

2. Key Contacts

   The applicant must complete the “Key Contacts” form found in the Grants.gov application package. An “Additional Key Contacts” form is also available at Forms and Standard Instructions Download Page. The Key Contacts form should also be completed for major sub-agreements (i.e., primary investigators). Do not include information for consultants or other contractors. Please make certain that all contact information is accurate.

   For Multiple PI applications: The Additional Key Contacts form must be completed (see Section I.F. for further information). Note: The Contact PI must be affiliated with the institution submitting the application. EPA will direct all communications related to scientific, technical, and budgetary aspects of the project to the Contact PI; however, any information regarding an application will be shared with any PI upon request. The Contact PI is to be listed on the Key Contact Form as the Project Manager/Principal Investigator (the term Project Manager is used on the Grants.gov form, the term Principal Investigator is used on the form located on NCER’s web site). For additional PIs, complete the Major Co-Investigator fields and identify PI status next to the name (e.g., “Name: John Smith, Principal Investigator”).

3. Table of Contents

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

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 described below (a-h). Examples of abstracts for current grants may be found on the NCER web site.

   1. Funding Opportunity Title and Number for this proposal.
   2. Project 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, use more commonly understood terminology. Do not use general phrases such as “research on.”
   3. Investigators: For applications with multiple investigators, state whether this is a single Lead PI (with co-PIs) or Multiple PI application (see Section I.F.). For Lead PI applications, list the Lead PI, then the name(s) of each co-PI who will significantly contribute to the project. For Multiple PI applications, list the Contact PI, then the name(s) of each additional PI. Provide a web site URL or an email contact address for additional information.
   4. Institution(s): 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 and Location: Show the proposed project beginning and ending dates and the performance sites/geographical location(s) where the work will be conducted.
   6. Project Cost: Show the total funding requested from the EPA (include direct and indirect costs for all years).
   7. Project Summary: Provide three subsections addressing: (1) the objectives of the study (including any hypotheses that will be tested), (2) the experimental approach to be used (a description of the proposed project), and (3) the expected results (outputs/outcomes) 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 may be found at: Forms and Standard Instructions Download Page.

5. Research Plan, Quality Assurance Statement, Non-Human Subjects Research Determination, Data Plan, and References

   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. This section should also include any background or introductory information that would help explain the objectives of the study. If this application is to expand upon 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.
      2. Approach/Activities: Outline the research design, methods, and techniques that you intend to use in meeting the objectives stated above.
      3. Innovation: Describe how your project shifts current research or engineering paradigms by using innovative theoretical concepts, approaches or methodologies, instrumentation or interventions applicable to one or more fields of research.
      4. Sustainability: Describe how your project embodies the principles of sustainability and seeks sustainable solutions that protect the environment and strengthen our communities. The Sustainability Primer (PDF) (2 pp, 195 K) provides examples of research activities that promote and incorporate sustainability principles.
      5. 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 and peer reviewers understand the merits of the research.
      6. General Project Information: Discuss other information relevant to the potential success of the project. This should include facilities, personnel expertise/experience, project schedules with associated milestones and target dates, 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.
      7. Appendices may be included but must remain within the 15-page limit.

   2. Quality Assurance Statement (3 pages)

      For projects involving environmental data collection or processing, 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.

      NOTE: If selected for award, applicants will be expected to provide additional quality assurance documentation.

      Address each applicable 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. (Not all will apply.)

      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. Identify the types of secondary data needed to satisfy the project objectives. Specify requirements relating to the type of data, the age of data, geographical representation, temporal representation, and technological representation, as applicable.
            2. Specify the source(s) of the secondary data and discuss the rationale for selection.
            3. Establish a plan to identify the sources of the secondary data in all deliverables/products.
            4. Specify quality requirements and discuss the appropriateness for their intended use. Accuracy, precision, representativeness, completeness, and comparability need to be addressed, if applicable.
            5. Describe the procedures for determining the quality of the secondary data.
            6. Describe the plan for data management/integrity.
         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).
      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.

   3. Non-Human Subjects Research Determination (1 page)

      This solicitation does not provide the opportunity for the submission of applications for projects that involve human subjects research. All human research studies conducted or supported by EPA are governed by EPA regulations at 40 CFR Part 26 (Protection of Human Subjects). This includes the Basic Federal Policy for the Protection of Human Research Subjects, also known as the Common Rule, at subpart A and additional prohibitions and special protections for pregnant women, nursing women, and children in research conducted or supported by EPA at subparts B, C, and D. Depending upon the type of research being conducted, additional subparts of 40 CFR Part 26 may be relevant. Procedures for the review and oversight of human research subject to 40 CFR Part 26 are also provided in EPA Order 1000.17 Change A1 (PDF) (41, 334 K).

      All applications submitted under this solicitation must include a Non-Human Subjects Research Determination, verifying that the proposed research will not involve human subjects (see definitions below).

      Definitions (from 40 CFR Part 26 Subparts A, B, and C)

      • Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information.
      • Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes
      • Interaction includes communication or interpersonal contact between investigator and subject.
      • Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
      • Individually identifiable means the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
      • Research involving the intentional exposure of a human subject means a study of a substance in which the exposure to the substance experienced by a human subject participating in the study would not have occurred but for the human subject’s participation in the study
      • Observational research means any human research that does not meet the definition of research involving intentional exposure of a human subject.

      Non-Human Subjects Research Determination Requirements

      Provide the following statement in your application package verifying that the proposed research will not involve human subjects: “The proposed research does not involve human subjects.” Please use the definitions provided above to ensure consistency in the interpretation of terminology.

   4. Data Plan (2 pages)

      Provide a plan to make all data resulting from an agreement under this RFA available in a format and with documentation/metadata such that they may be used by others in the scientific community. This includes data first produced under the award, i.e., from observations, analyses, or model development collected or used under the agreement. Applicants who plan to develop or enhance databases containing proprietary or restricted information must provide, within the two pages, a strategy to make the data widely available, while protecting privacy or property rights.

   5. References: References cited are in addition to other page limits (e.g. research plan, quality assurance statement, data plan).

6. Budget and Budget Justification

   1. Budget

      Prepare a master budget table using “SF-424A Budget Information for Non-Construction Programs” (aka SF-424A), available in the Grants.gov electronic application package and also at Forms and Standard Instructions Download Page. Only complete “Section B-Budget Categories”. Provide the object class budget category (a. - k.) amounts for each budget year under the “Grant Program, Function or Activity” heading. Each column reflects a separate budget year. For example, Column (1) reflects budget year 1. The total budget will be automatically tabulated in column (5).

      If a subaward is included in the application, provide a separate SF-424A and budget justification for the subaward. Include the total amount for the subaward under “Other” in the master SF-424A.

      Applicants may not use subagreements to transfer or delegate their responsibility for successful completion of their EPA assistance agreement. Therefore, EPA expects that subawards or subcontracts should not constitute more than 40% of the total direct cost of the total project budget. If a subaward/subcontract constitutes more than 40% of the total direct cost, additional justification may be required before award, discussing the need for the subaward/subcontract to accomplish the objectives of the research project. Please see Section IV. D below if your organization intends to identify specific contractors, including consultants, and subawardees in your proposal.

      Please note that institutional cost-sharing is not required. However, if voluntary cost-sharing is proposed, a brief statement concerning cost-sharing should be added to the budget justification.

      Please note that when formulating budgets for proposals/applications, applicants must not include management fees or similar charges in excess of the direct costs and indirect costs at the rate approved by the applicant’s cognizant audit agency, or at the rate provided for by the terms of the agreement negotiated with EPA. The term "management fees or similar charges" refers to expenses added to the direct costs in order to accumulate and reserve funds for ongoing business expenses, unforeseen liabilities, or for other similar costs that are not allowable under EPA assistance agreements. Management fees or similar charges may not be used to improve or expand the project funded under this agreement, except to the extent authorized as a direct cost of carrying out the scope of work.

   2. Budget Justification [2 pages in addition to the Section IV.B.5. page limitations, not including additions under No. (7) below to support subawards]

      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, total cost for the budget period, and project role. Compensation paid for employees engaged in grant activities must be consistent with payments for similar work within the applicant organization. Note that for salaries to be allowable as a direct charge to the award, a justification of how that person will be directly involved in the project must be provided. General administrative duties such as answering telephones, filing, typing, or accounting duties are not considered acceptable. Below is a sample computation for Personnel:

         Position/Title	Annual Salary	% of Time Assigned to Project	Cost
         Project Manager	$70,000	50%	$ 35,000
         Env. Specialist	$60,000	100%	$ 60,000
         Env. Health Tech	$45,000	100%	$ 45,000
         Total Personnel			$140,000

         Note this budget category is limited to persons employed by the applicant organization ONLY. Those employed elsewhere are classified as subawardees, contractors or consultants. Contractors and consultants should be listed under the “Contractual” budget heading while subawards made to eligible subrecipients are listed under the “Other” budget heading.

      2. Fringe Benefits: Identify the percentage used and the basis for its computation. Fringe benefits are for the personnel listed in budget category (1) above and only for the percentage of time devoted to the project. Fringe benefits include but are not limited to the cost of leave, employee insurance, pensions and unemployment benefit plans. The applicant should not combine the fringe benefit costs with direct salaries and wages in the personnel category.

      3. Travel: Specify the estimated number of trips, purpose of each trip, number of travelers per trip, destinations, and other costs for each type of travel. Explain the need for any travel, paying particular attention to travel outside the United States. Include travel funds for annual STAR program progress reviews (estimate for two days in Washington, D.C.) and a final workshop to report on results.

         Below is a sample computation for Travel:

         Purpose of Travel	Location	Item	Computation	Cost
         EPA STAR Progress Review	DC	Lodging	4 people x $100 per night x 2 nights	$800
         		Airfare	4 people x $500 round trip	$2,000
         		Per Diem	4 people x $50 per day x 2 days	$400
         Total Travel				$3,200

      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. Details such as the type of equipment, cost, and a brief narrative on the intended use of the equipment for project objectives are required. Each item of equipment must be identified with the corresponding cost. General-purpose equipment (office equipment, etc.) must be justified as to how it will be used on the project. (Property items with a unit cost of less than $5,000 are considered supplies.)

      5. Supplies: “Supplies” means tangible property other than “equipment.” Identify supplies to be used under the project. This may include: software, office supplies, and laboratory supplies such as reagents, chemicals and glassware. Specifically identify computers to be purchased or upgraded.

      6. Contractual: Specify the amount you anticipate expending for services/analyses or consultants and specify the purpose of the contracts and estimated cost. Any procurement of services from individual consultants or commercial firms (including space for workshops) must comply with the competitive procurement requirements of 40 CFR Part 30.40-30.48 or 40 CFR 31.36, as appropriate. Please see Section IV. D below for more details.

         Examples of Contractual costs include:

         1. Consultants – Consultants are individuals with specialized skills who are paid at a daily or hourly rate. EPA’s participation in the salary rate (excluding overhead) paid to individual consultants retained by recipients or by a recipient's contractors or subcontractors is limited to the maximum daily rate for a Level IV of the Executive Schedule (formerly GS-18), to be adjusted annually.
         2. Equipment Rental – When there is a need to rent equipment for use on the project, provide information on the type of equipment to be rented, the purpose or use on the project, the length of time needed and the rental rate. Renting or leasing of equipment will require a lease vs. purchase cost analysis prior to approval.
         3. Facility Rental – When it is necessary to rent office or other facilities spaces for project implementation, and the space(s) are located off-site from the organization’s main facility in space not owned by the applicant organization, the cost of the rent may be charged against the award as a contractual expense if the space is used specifically for the project. The budget justifications should provide details on the monthly rental charge and if the rent is pro-rated to the project.
         4. Service or Maintenance Contracts – Costs should be in direct correlation to the use of the equipment for the project (i.e., if a particular machine is used 50% of the time for the project, the project should only be charged 50% of the service/maintenance costs). Provide details of the type of equipment and the amount of the service contract to be paid from EPA funds.
         5. Speaker/Trainer Fees – Information on speakers should include the fee and a description of the services they are providing.

      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. “Other” items may include publication costs, long distance telephone charges, and photocopying costs. Note that subawards, such as those with other universities for members of the research team, are included in this category. Subawards must have a separate itemized budget and budget justification, not to exceed one additional page each. Subawards may not be used to acquire services from consultants or commercial firms. Please see Section IV.D below for more details.

      8. Indirect Costs: Indirect costs are those incurred by the applicant for a common or joint purpose that benefit more than one cost objective or project, and are not readily assignable to specific cost objectives or projects as a direct cost. In order for indirect costs to be allowable, the applicant must have a negotiated indirect cost rate (e.g., fixed, predetermined, final or provisional), or must have submitted a proposal to their cognizant agency. If indirect costs are included in the budget, identify the cognizant agency and the approved indirect rate. If your organization does not have a cognizant agency, please note that in the budget justification and provide a brief explanation for how you calculated your indirect cost rate.

7. Resumes

   Provide resumes for each investigator and important co-worker. You may include resumes from staff of subawardees such as universities. Do not include resumes of consultants or other contractors. 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

   Complete a current and pending support form (provided at Forms and Standard Instructions Download Page) for each investigator and important co-worker. Do not include current and pending support for consultants or other contractors. Include all current and pending research regardless of source.

   Note to all prospective applicants requiring multiple Current and Pending Support Form pages: Due to a limitation in Adobe Acrobat's forms functionality, additional pages cannot be directly inserted into the original PDF form and preserve the form data on the subsequent pages. Multiple page form submissions can be created in Acrobat 8 and later using the "PDF Package" option in the "Create PDF from Multiple Files" function. If you have an earlier version of Adobe Standard or Professional, applicants will need to convert each PDF page of the form to an EPS (Encapsulated Post Script) file before creating the PDF for submission. The following steps will allow applicants with earlier versions of Adobe Standard or Professional to create a PDF package:

   1. Populate the first page of the PDF, and save it as a EPS (Encapsulated Post Script) file.
   2. Reopen the form, and populate it with the data for page 2. Save this page as a different EPS file. Repeat for as many pages as necessary.
   3. Use Acrobat Distiller to convert the EPS files back to PDF.
   4. Open Acrobat Professional, and combine the individual pages into a combined PDF file.

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 document 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. EPA employees are not permitted to provide letters of intent for any application.

      Letters of support do not commit a resource vital to the success of the proposal. A letter of support is written by businesses, organizations, or community members stating their support of the applicant's proposed project. EPA employees are not permitted to provide letters of support for any application.

      Note: Letters of intent or support must be part of the application; letters submitted separately will not be accepted. Any letter of intent or support that exceeds one brief paragraph (excluding letterhead and salutations), is considered part of the Research Plan and is included in the 15-page Research Plan limit. Any transactions between the successful applicant and parties providing letters of intent or support financed with EPA grant funds are subject to the funding restrictions described in Section IV. D. as well.

   2. Funding Opportunity Number(s) (FON)

      At various places in the application, applicants are asked to identify the FON.

      The Funding Opportunity Number for this RFA is:

      Development and Use of Adverse Outcome Pathways that Predict Adverse Developmental Neurotoxicity, EPA-G2012-STAR-F1

   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.

      EPA recommends that you do not include confidential business information (“CBI”) in your proposal/application. However, if confidential business information is included, it will be treated in accordance with 40 CFR 2.203. Applicants must clearly indicate which portion(s) of their proposal/application they are claiming as CBI. EPA will evaluate such claims in accordance with 40 CFR Part 2. If no claim of confidentiality is made, EPA is not required to make the inquiry to the applicant otherwise required by 40 CFR 2.204(c)(2) prior to disclosure. The Agency protects competitive proposals/applications from disclosure under applicable provisions of the Freedom of Information Act prior to the completion of the competitive selection process.

   4. Pre-proposal/Application Assistance and Communications

      In accordance with EPA's Assistance Agreement Competition Policy (EPA Order 5700.5A1), EPA staff will not meet with individual applicants to discuss draft proposals, provide informal comments on draft proposals, or provide advice to applicants on how to respond to ranking criteria. Applicants are responsible for the contents of their applications/proposals. However, consistent with the provisions in the announcement, EPA will respond to questions from individual applicants regarding threshold eligibility criteria, administrative issues related to the submission of the proposal, and requests for clarification about the announcement. In addition, if necessary, EPA may clarify threshold eligibility issues with applicants prior to making an eligibility determination.

C. Submission Dates and Times
Applications must be transferred to Grants.gov no later than 11:59:59 pm Eastern Time on the solicitation closing date.  Applications transferred after the closing date and time will be returned to the sender without further consideration.  EPA will not accept any changes to applications after the closing date.

It should be noted that this schedule may be changed without prior notification because of factors not anticipated at the time of announcement.  In the case of a change in the solicitation closing date, a new date will be posted on the NCER web site (Funding Opportunities) and a modification posted on Grants.gov. 

Solicitation Closing Date: December 12, 11:59:59 pm Eastern Time (applications must be submitted to Grants.gov by this time, see Section IV.E “Submission Instructions and Other Submission Requirements” for further information).

NOTE: Customarily, applicants are notified about evaluation decisions within six months of the solicitation closing date.  Awards are generally made 9-12 months after the solicitation closing date.

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(s).

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.

EPA awards funds to one eligible applicant as the recipient even if other eligible applicants are named as partners or co-applicants or members of a coalition or consortium.  The recipient is accountable to EPA for the proper expenditure of funds.

Funding may be used to provide subgrants or subawards of financial assistance, which includes using subawards or subgrants to fund partnerships,  provided the recipient complies with applicable requirements for subawards or subgrants including those contained in 40 CFR Parts 30 or 31, as appropriate.   Applicants must compete contracts for services and products, including consultant contracts, and conduct cost and price analyses to the extent required by the procurement provisions of the regulations at 40 CFR Parts 30 or 31, as appropriate. The regulations also contain limitations on consultant compensation. Applicants are not required to identify subawardees/subgrantees and/or contractors (including consultants) in their proposal/application.  However, if they do, the fact that an applicant selected for award has named a specific subawardee/subgrantee, contractor, or consultant in the proposal/application EPA selects for funding does not relieve the applicant of its obligations to comply with subaward/subgrant and/or competitive procurement requirements as appropriate.   Please note that applicants may not award sole source contracts to consulting, engineering or other firms assisting applicants with the proposal based solely on the firm's role in preparing the proposal/application. 

Successful applicants cannot use subgrants or subawards to avoid requirements in EPA grant regulations for competitive procurement by using these instruments to acquire commercial services or products from for-profit organizations to carry out its assistance agreement.  The nature of the transaction between the recipient and the subawardee or subgrantee must be consistent with the standards for distinguishing between vendor transactions and subrecipient assistance under Subpart B Section .210 of OMB Circular A-133, and the definitions of subaward at 40 CFR 30.2(ff) or subgrant at 40 CFR 31.3, as applicable. EPA will not be a party to these transactions.  Applicants acquiring commercial goods or services must comply with the competitive procurement standards in 40 CFR Part 30 or 40 CFR Part 31.36 and cannot use a subaward/subgrant as the funding mechanism.  

Section V of the announcement describes the evaluation criteria and evaluation process that will be used by EPA to make selections under this announcement.  During this evaluation, except for those criteria that relate to the applicant's own qualifications, past performance, and reporting history, the review panel will consider, if appropriate and relevant, the qualifications, expertise, and experience of:

1. an applicant's named subawardees/subgrantees identified in the proposal/application if the applicant demonstrates in the proposal/application that if it receives an award that the subaward/subgrant will be properly awarded consistent with the applicable regulations in 40 CFR Parts 30 or 31.  For example, applicants must not use subawards/subgrants to obtain commercial services or products from for profit firms or individual consultants. 
2. an applicant's named contractor(s), including consultants, identified in the proposal/application if the applicant demonstrates in its proposal/application that the contractor(s) was selected in compliance with the competitive procurement standards in 40 CFR Part 30 or 40 CFR 31.36 as appropriate.  For example, an applicant must demonstrate that it selected the contractor(s) competitively or that a proper non-competitive sole-source award consistent with the regulations will be made to the contractor(s), that efforts were made to provide small and disadvantaged businesses with opportunities to compete, and that some form of cost or price analysis was conducted.   EPA may not accept sole source justifications for contracts for services or products that are otherwise readily available in the commercial marketplace.

EPA will not consider the qualifications, experience, and expertise of named subawardees/subgrantees and/or named contractor(s) during the proposal/application evaluation process unless the applicant complies with these requirements.

Each proposed project must be able to be completed within the project period and with the initial award of funds.  Applicants should request the entire amount of money needed to complete the project.  Recipients should not anticipate additional funding beyond the initial award of funds for a specific project.  

E. Submission Instructions and Other Submission Requirements
Please read this entire section before attempting an electronic submission through Grants.gov. 

If you do not have the technical capability to utilize the Grants.gov application submission process for this solicitation, call 1-800-490-9194 or send a webmail message at least 15 calendar days before the submission deadline to assure timely receipt of alternate submission instructions.  In your message  provide the funding opportunity number and title of the program, specify that you are requesting alternate submission instructions, and provide a telephone number, fax number, and an email address, if available.  Alternate instructions will be emailed whenever possible.  Any applications submitted through alternate submission methods must comply with all the provisions of this RFA, including Section IV, and be received by the solicitation closing date identified above.

Note:  Grants.gov submission instructions are updated on an as-needed basis.  Please provide your Authorized Organizational Representative (AOR) with a copy of the following instructions to avoid submission delays that may occur from the use of outdated instructions.

1. Preparing for Submission.  The appropriate electronic application package available through the Grants.gov site must be used for electronic submissions.  To begin the application process, go to Grants.gov and click on the “Apply for Grants” tab on the left side of the page.  Then click on “Apply Step 1:  Download a Grant Application Package” to download the compatible Adobe viewer and obtain the application package.  For more information on Adobe Reader please go to Grants.gov Help page. 

   Note:Grants.gov is aware of a corruption issue when Adobe Reader application packages are saved in different versions of Adobe Reader.  It is recommended that applicants uninstall earlier versions of Adobe Reader and then install the version available and compatible through Grants.gov.

   The application package may be quickly accessed from Download Application Package using the appropriate FON.  Be sure to download the electronic application package for the appropriate FON.   Please register for announcement change notification emails.  Note: With the exception of the current and pending support form (available at Forms and Standard Instructions Download Page), all necessary forms are included in the electronic application package.

   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.  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.  Note for organizations not currently registered: the registration process may take a week or longer to complete.  We recommend you designate an AOR and begin the registration process as soon as possible.

   For more information, go to Grants.gov and click on “Get Registered”. 

2. Acknowledgement of Receipt.  The complete application must be transferred to Grants.gov no later than 11:59:59 pm Eastern Time on the solicitation closing date (see “Submission Dates and Times”).  Grants.gov provides an on-screen notification of successful initial transfer as well as an email 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 email acknowledgement sent by NCER to the Lead/Contact PI and the Administrative Contact.  This email will be sent from receipt.application@epa.gov; emails to this address will not be accepted.  If an email acknowledgment from receipt.application@epa.gov has not been received within 30 days of the solicitation closing date, immediately inform the Eligibility Contact shown in this solicitation.  Failure to do so may result in your application not being reviewed.

3. Application Package Preparation.  The application package consists of a. through d. below. 

   1. Application for Federal Assistance (SF 424):  Complete the form except for the “competition ID” field.
   2. EPA Key Contacts Form 5700-54:  Complete the form.  If additional pages are needed, see (d) below.
   3. SF-424A Budget Information for Non-Construction Programs: Only complete “Section B-Budget Categories”.   Provide the object class budget category (a. - k.) amounts for each budget year under the “Grant Program, Function or Activity” heading.  Each column reflects a separate budget year.
   4. Project Narrative Attachment Form (click on “Add Mandatory Project Narrative”):  Attach a single electronic file labeled “Application” that contains the items described in Section IV.B.3. through IV.B.9.a (Table of Contents, Abstract, Research Plan, Quality Assurance Statement, Non-Human Subjects Research Determination, Data Plan, References, Budget Justification, Resumes, Current and Pending Support, and Letters of Intent/Support) of this solicitation.  In order to maintain format integrity, this file must be submitted in Adobe Acrobat PDF.  Please review the PDF 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. If Key Contacts Continuation pages (see Forms and Standard Instructions Download Page) are needed, place them before the Table of Contents (Section IV.B.3.). 

   Please note that applicants are limited to using the following characters in all attachment file names.  Valid file names may only include the following UTF-8 characters:
   A-Z, a-z, 0-9, underscore ( _ ), hyphen (-), space, period. If applicants use any other characters when naming their attachment files their applications will be rejected by grants.gov.

   Once the application package has been completed, the “Submit” button should be enabled.  If the “Submit” button is not active, please call Grants.gov for assistance at 1-800-518-4726.  Applicants who are outside the U.S. at the time of submittal and are not able to access the toll-free number may reach a Grants.gov representative by calling 606-545-5035.  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 or a revised application needs to be submitted.  Note:  Revised applications must be submitted before the solicitation closing date and time.

4. Submitting the application.  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 ensure that your application is submitted to Grants.gov BEFORE 11:59:59 pm Eastern Time on the solicitation closing date.  The Grants.gov support desk operates 24 hours a day, seven days a week, except Federal Holidays.

   A successful transfer will end with an on-screen acknowledgement.  For documentation purposes, print or screen capture this acknowledgement.  If a submission problem occurs, reboot the computer – turning the power off may be necessary – and re-attempt the submission. 

   Note:  Grants.gov issues a “case number” upon a request for assistance.

5. Transmission Difficulties.  If transmission difficulties that result in a late transmission, no transmission, or rejection of the transmitted application are experienced, and following the above instructions do not resolve the problem so that the application is submitted to Grants.Gov by the deadline date and time, follow the guidance below.  The Agency will make a decision concerning each late submission on a case-by-case basis as to whether it should be forwarded for peer review.  All emails, as described below, are to be sent to peterson.todd@epa.gov with the FON in the subject line.

   Please note that if the application you are submitting is greater than 70 MB in size, please call or send an email message to the Electronic Submissions Contact listed for this RFA.  The Agency may experience technical difficulty downloading files of this size from Grants.gov.  Therefore, it is important that the Agency verify that the file can be downloaded.  The Agency will provide alternate submission instructions if the file cannot be downloaded.

   1. If you are experiencing problems resulting in an inability to upload the application to Grants.gov, it is essential to call Grants.gov for assistance at 1-800-518-4726 before the application deadline.  Applicants who are outside the U.S. at the time of submittal and are not able to access the toll-free number may reach a Grants.gov representative by calling 606-545-5035.  Be sure to obtain a case number from Grants.gov.
   2. Unsuccessful transfer of the application package: If a successful transfer of the application cannot be accomplished even with assistance from Grants.gov due to electronic submission issues, send an email message by 11:59:59 pm Eastern Time on the solicitation closing date. The email message must document the problem and include the Grants.gov case number as well as the entire application in PDF format as an attachment.
   3. Grants.gov rejection of the application package:  If a notification is received from Grants.gov stating that the application has been rejected for reasons other than late submittal, promptly send an email to Todd Peterson (peterson.todd@epa.gov) with the FON in the subject line within one business day of the closing date of this solicitation.  The email should include any materials provided by Grants.gov and attach the entire application in PDF format.

V. APPLICATION REVIEW INFORMATION

A. Peer Review
All eligible grant applications are reviewed by appropriate external technical peer reviewers   based on the criteria and process described below.  This review is designed to evaluate each application according to its scientific merit.  The individual external peer reviewers include 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.

Prior to the external technical peer review panel meeting, all reviewers will receive electronic copies of all applications to be reviewed by the entire panel, as well as a full set of abstracts for the applications. Each application will be assigned to a minimum of three primary peer reviewers, one of whom will be assigned the role of Rapporteur. Each reviewer will be assigned up to approximately 10 applications on which to serve as a primary reviewer. During the review period leading up to the panel meeting, primary reviewers will read the full set of abstracts and entire application package for each application they are assigned. They will also prepare a written individual evaluation for each assigned application that addresses the peer review criteria described below and rate the application with a score of excellent, very good, good, fair, or poor. 

At the beginning of the panel meeting, each primary reviewer will report their ratings for the applications they reviewed.  Those applications receiving at least two ratings of Very Good or one rating of Excellent from among the primary reviewers will then be further discussed by the entire panel as described below.  In addition, if there is one Very Good rating among the primary reviewers of an application, the primary reviewer, whose initial rating is the Very Good, may request discussion of the application by the entire peer review panel.  All other applications will be declined for further consideration. 

The panelists will document their evaluation for each application based on the peer review criteria stated below and assign a score (excellent, very good, good, fair, or poor) to each application.  After the discussion of an application by the entire panel, the three primary reviewers may revise their initial ratings and if they do so, this will also be documented.

The final ratings of the primary reviewers and the ratings of the other panelists will then be translated by EPA into the final peer review score (excellent, very good, good, fair, or poor) for the application. This is reflected in a peer review results document developed by the Rapporteur, which combines the individual initial and final evaluations of the three primary reviewers, the non-primary reviewer panelists’evaluation documentation, and may also capture any substantive comments from the panel discussion.   This score will be used to determine which applications undergo the internal programmatic review discussed below.  A peer review results document is also developed for applications that are not discussed. However this document is a consolidation of the three individual primary reviewer initial evaluations, with an average of the three scores assigned by the primary reviewers.           

Peer reviewers consider 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 “1h” are 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. Practical and technically defensible approach that can be performed within the proposed time period.
   3. Research contributes to scientific knowledge in the topic area.
   4. The proposed research challenges and seeks to shift current research or engineering paradigms by using innovative theoretical concepts, approaches or methodologies, instrumentation or interventions applicable to one or more fields of research
   5. Projected benefits of the proposed activity to society, such as improving the environment or human health.
   6. The proposed research embodies the principles of sustainability and seeks sustainable solutions that protect the environment and strengthen our communities. The Sustainability Primer (PDF) (2 pp, 195 K) provides examples of research activities that promote and incorporate sustainability principles.
   7. The results are disseminated broadly to enhance scientific and technological understanding.
   8. The proposal is 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. All key personnel must make a significant time commitment to the project.
3. Responsiveness: The responsiveness of the proposal to the research needs identified for the research area. The proposal adequately addresses the objectives and special considerations specified by the RFA.
4. Facilities and equipment: The availability and/or adequacy of the facilities and equipment proposed for the project. Note 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.

B. Programmatic Review
Applications receiving final peer review scores of excellent or very good 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.

Those applicants who received final 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 PI’s (in the case of Multiple-PI applications, the Contact PI’s) "Past Performance and Reporting History."  The applicant must provide the EPA Project Officer with information on the proposed Lead/Contact PI's past performance and reporting history under prior Federal agency assistance agreements (assistance agreements include grants and cooperative agreements but not contracts) in terms of: (i) the level of success in managing and completing each agreement, and (ii) history of meeting the reporting requirements under each agreement.

This information is required only for the proposed Lead/Contact 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 required for each agreement 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; excess pages will not be reviewed.  Note: If no prior past performance information and/or reporting history 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 managed and completed; if not successfully managed and completed, provide an explanation.
6. Information relating to the proposed Lead/Contact PI's past performance in reporting on progress towards achieving the expected results (outputs/outcomes) under the agreement.  Include the history of submitting timely progress/final technical reports, describe how progress towards achieving the expected results was reported/documented, and if such progress was not being made, provide 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 Email address (if available).

The purpose of the programmatic review is to ensure 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.

The internal programmatic review panel will assess (relevance is more important than the Lead/Contact PI's past performance):

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

C. Funding Decisions
Final funding decisions are made by the NCER Director based on the results of the peer review and the internal programmatic review. In addition, in making the final funding decisions, the NCER Director may also consider program balance and available funds.  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 and Interagency Agreement Management Division for award in accordance with the EPA’s procedures.

VI. AWARD ADMINISTRATION INFORMATION

A. Award Notices
Customarily, applicants are notified about evaluation decisions within six months of the solicitation closing date.  A Peer Review Results document summarizing the scientific review  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 and/or submit a revised budget.  EPA Project Officers will contact the Lead PI/Contact PI to obtain these materials.  Before or after an award, applicants may be required to provide additional quality assurance documentation.

Non-profit applicants that are recommended for funding under this announcement are subject to pre-award administrative capability reviews consistent with Sections 8b., 8c. and 9d. of EPA Order 5700.8 - Policy on Assessing Capabilities of Non-Profit Applicants for Managing Assistance Awards (PDF) (10 pp, 42 K). In addition, non-profit applicants that qualify for funding may, depending on the size of the award, be required to fill out and submit to the Grants Management Office the Administrative Capabilities Form with supporting documents contained in Appendix A of EPA Order 5700.8.

The official notification of an award will be made by the Agency’s Grants and Interagency Agreement Management Division.  Applicants are cautioned that only a grants officer is authorized to 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.  For example, statutory authorization, funding, or other issues discovered during the award process may affect the ability of EPA to make an award to an applicant. The award notice, signed by an EPA grants officer, is the authorizing document and will be provided through electronic or postal mail.

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 Dispute Resolution Procedures.  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 Guidance & Frequent Questions 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 of changes may be required from EPA. Examples of these changes are contained in 40 C.F.R. 30.25.  Note: prior written approval is also required from the EPA Award Official for incurring costs more than 90 calendar days prior to award.

3. Human Subjects: This solicitation does not provide the opportunity for the submission of applications for projects that involve human subjects research.  Human subjects research supported by the EPA is governed by EPA Regulation 40 CFR Part 26 (Protection of Human Subjects).   Applications proposing human subjects research will not be considered for funding and will be deemed ineligible.  Human subjects research precluded from this RFA includes projects that collect data from or about humans which meet the regulatory definition of research with human subjects and are thereby subject to the requirements of EPA Regulation 40 CFR Part 26 and EPA Order 1000.17 Change A1.  This includes projects conducted under programs that are not considered research for other purposes. For example, some demonstration programs and some public health practice programs may include research activities. Projects that utilize surveys about people or contain identifiable private information also constitutes human subjects research and are not allowable under this solicitation.  The assistance agreement will include a term and condition prohibiting any human subjects research from being performed under the grant award.

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 first produced under the award 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 the EPA Information Quality Guidelines (EPA IQG) page.  These procedures may apply to data generated by grant recipients if those data are disseminated as described in the Guidelines.

   EPA has the right to obtain, reproduce, publish, or otherwise use the data first produced under the award; and authorize others to receive, reproduce, publish, or otherwise use such data for Federal purposes, under 40 C.F.R. § 30.36(c). In addition, pursuant to 40 C.F.R. § 30.36(d), if EPA receives a Freedom of Information Act request for research data that (1) relates to published research findings produced under an EPA award and (2) was used by the Federal Government in developing an agency action that has the force and effect of law, then EPA shall request, and the award recipient shall provide, within a reasonable time, the research data so that it may be made available to the public through procedures established under the FOIA.

6. Reporting:  A grant recipient is expected to manage assistance agreement funds efficiently and effectively and make sufficient progress towards completing the project activities described in the research plan in a timely manner.  The assistance agreement will include terms/conditions implementing this requirement.

   A grant recipient must agree to provide annual progress reports, with associated summaries, and a final report with an executive summary.  The summaries will be posted on NCER’s website.

   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 NCER 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 or another as specified by NCER’s project officer:

   This publication [article] was made possible by EPA grant number _______.  Its contents are solely the responsibility of the grantee and do not necessarily represent the official views of the EPA.  Further, the EPA does not endorse the purchase of any commercial products or services mentioned in the publication.

   A graphic that may be converted to a slide or used in other ways, such as on a poster, is located at Guidance & Frequent Questions.  EPA expects recipients to use this graphic in oral and poster presentations.

8. Subaward and Executive Compensation Reporting: Applicants must ensure that they have the necessary processes and systems in place to comply with the sub-award and executive total compensation reporting requirements established under OMB guidance at 2 CFR Part 170, unless they qualify for an exception from the requirements, should they be selected for funding.

9. Central Contractor Registration (CCR)/System for Award Management (SAM) and Data Universal Numbering System (DUNS) Requirements:   Unless exempt from these requirements under OMB guidance at 2 CFR Part 25 (e.g., individuals), applicants must:

   1. Be registered in the CCR prior to submitting an application or proposal under this announcement. CCR/SAM information can be found at SAM web site.
   2. Maintain an active CCR registration with current information at all times during which it has an active Federal award or an application or proposal under consideration by an agency, and
   3. Provide its DUNS number in each application or proposal it submits to the agency. Applicants can receive a DUNS number, at no cost, by calling the dedicated toll-free DUNS Number request line at 1-866-705-5711, or visiting the D&B website .

   If an applicant fails to comply with these requirements, it will, should it be selected for award, affect their ability to receive the award.

   Please note that the CCR has been replaced by the System for Award Management (SAM). To learn more about SAM, go to SAM Welcome Page or SAM web site.

10. Exchange Network: EPA, states, territories, and tribes are working together to develop the National Environmental Information Exchange Network, a secure, Internet- and standards-based way to support electronic data reporting, sharing, and integration of both regulatory and non-regulatory environmental data.  States, tribes and territories exchanging data with each other or with EPA, should make the Exchange Network and the Agency's connection to it, the Central Data Exchange (CDX), the standard way they exchange data and should phase out any legacy methods they have been using.  More information on the Exchange Network is available at Exchange Network website. .

11. Website References in Solicitation: Any non-federal websites or website links included in this solicitation are provided for proposal preparation and/or informational purposes only.  U.S. EPA does not endorse any of these entities or their services.  In addition, EPA does not guarantee that any linked, external websites referenced in this solicitation comply with Section 508 (Accessibility Requirements) of the Rehabilitation Act.

12. Unpaid Federal Tax Liabilities and Felony Convictions for Non-Profit and For-Profit Organizations: Awards made under this announcement are subject to the provisions contained in the Department of Interior, Environment, and Related Agencies Appropriations Act, 2012, HR 2055, Division E. Sections 433 and 434 regarding unpaid federal tax liabilities and federal felony convictions. These provisions prohibit EPA from awarding funds made available by the Act to any for-profit or non-profit organization: (1) subject to any unpaid Federal tax liability that has been assessed, for which all judicial and administrative remedies have been exhausted or have lapsed, and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability; or (2) that was convicted (or had an officer or agent of such corporation acting on its behalf convicted) of a felony criminal conviction under any Federal law within 24 months preceding the award, unless EPA has considered suspension or debarment of the corporation, or such officer or agent, based on these tax liabilities or convictions, and determined that such action is not necessary to protect the Government’s interests. Non-profit or for-profit organizations that are covered by these prohibitions are ineligible to receive an award under this announcement.

13. Unfair Competitive Advantage:  EPA personnel will take appropriate actions in situations where it is determined that an applicant may have an unfair competitive advantage, or the appearance of such, in competing for awards under this announcement.  Affected applicants will be provided an opportunity to respond before any final action is taken.

VII. AGENCY CONTACTS

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

Eligibility Contact: Bronda Harrison (harrison.bronda@epa.gov); phone: 703-347-8080
Electronic Submissions: Todd Peterson (peterson.todd@epa.gov ); phone: 703-308-7224
Technical Contact: Mitch Lasat (lasat.mitch@epa.gov); phone: 703-347-8099

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