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Extramural Research

EPA Regulatory, Statutory, Programmatic and Policy Requirements for the EPA/NSF Networks for Characterizing Chemical Life Cycle (NCCLCs) and EPA/NSF Networks for Sustainable Molecular Design and Synthesis (NSMDS)

Research Project Search

Extramural Research Search

Note: For those proposals that are selected for potential funding by EPA, the PI will be required to withdraw the proposal from NSF and resubmit it to EPA.  PIs invited to resubmit to EPA will receive further information on resubmission procedures from an EPA Project Officer. The following guidance regarding EPA-specific requirements is provided for use only with those proposals that will be resubmitted to EPA after the conclusion of the joint review process.

SUMMARY OF PROGRAM REQUIREMENTS

SECTION I. INTRODUCTION

Human Subjects

This solicitation provides the opportunity for the submission of applications for projects that may involve human subjects research.  Human subjects research supported by the EPA is governed by EPA Regulation 40 CFR Part 26 (Protection of Human Subjects).  This includes the Common Rule at subpart A and prohibitions and additional protections for pregnant women and fetuses, nursing women, and children at subparts B, C, and D.  Research meeting the regulatory definition of intentional exposure research found in subpart B is prohibited by that subpart in pregnant women, nursing women, and children.  Research meeting the regulatory definition of observational research found in subparts C and D is subject to the additional protections found in those subparts for pregnant women and fetuses (subpart C) and children (subpart D).  All applications must include a Human Subjects Research Statement (HSRS, as described below), and if the project involves human subjects research, it will be subject to an additional level of review prior to funding decisions being made as described below.

Guidance and training for investigators conducting EPA-funded research involving human subjects may be obtained here:
Ethics, Regulations, and Policies
Human Subjects Research at the Environmental Protection Agency: Ethical Standards and Regulatory Requirements

Statutory Authority and Applicable Regulations

EPA's authority for this solicitation and resulting awards is contained in the: Safe Drinking Water Act, Section 1442, 42 U.S.C. 300j-1; Toxic Substances Control Act, Section 10, 15 U.S.C. 2609; Federal Insecticide, Fungicide, and Rodenticide Act, Section 20, 7 U.S.C. 136r; Clean Air Act, Section 103, 42 U.S.C. 7403; Clean Water Act, Section 104, 33 U.S.C. 1254; Solid Waste Disposal Act, Section 8001, 42 U.S.C. 6981.

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.

Human Subjects

This solicitation provides the opportunity for the submission of applications for projects that may involve human subjects research.  There are many scientific and ethical considerations that must be addressed in such studies by the study sponsor and research team, including, but not limited to, those related to recruitment, retention, participant compensation, third-party issues, researcher-participant interactions, researcher-community interactions, communications, interventions, and education.  All such research must comply with the requirements of 40 CFR Part 26, and any human observational exposure studies must also adhere to the principles set forth in the Scientific and Ethical Approaches for Observational Exposure Studies (133 pp, 1.21 MB) (SEAOES) (EPA/600/R-08/062) document.  SEAOES, which was published by researchers in EPA and which discusses the principles for the ethical conduct of human research studies, serves as a resource for applicants interested in applying under this solicitation.  References to “SEAOES Principles” in this solicitation refers, in general, to the issues of interest in conducting human subjects research studies that maintain the highest scientific and ethical standards and safety during the conduct of these studies.  All applications must include a Human Subjects Research Statement (HSRS; described below) and if the project involves human subjects research, it will be subject to an additional level of review prior to funding decisions being made as described below.

SECTION V. PROPOSAL PREPARATION AND SUBMISSION INSTRUCTIONS

Intergovernmental Review of Federal Programs

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.

Quality Assurance Documentation

EPA will require the recipient to submit a Quality Management Plan (QMP) that documents the organization's quality program in terms of organizational structure, policy and procedures, functional responsibilities, lines of authority and required interfaces for those planning, implementing, documenting and assessing all activities conducted across multiple projects.  This is not required for application submission, but will be required for any applications that EPA chooses to recommend for funding. More detailed information on requirements can be found at Guidance & Frequent Questions. The QMP shall designate one individual to serve as Quality Assurance Manager (QAM) for the Network.  This individual is responsible for implementing the Network's quality system and coordinating the QA/QC activities within the Network.  The QAM cannot be the lead or co-Principle Investigator and shall be independent of data collection and use activities. 

EPA Human Subjects Research Statement (HSRS) (6 pages)

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 pp, 334 K). These include review of projects for EPA-supported human research by the EPA Human Subjects Research Review Official (HSRRO).  EPA Order 1000.17 Change A1 requires preliminary approval by the HSRRO of all proposed EPA-supported human research before the agreement can be entered into.  Additional requirements must be met and final approval received from the HSRRO before the research can begin.  When reviewing human observational exposure studies, EPA Order 1000.17 Change A1 requires the HSRRO to apply the principles described in the SEAOES document (Scientific and Ethical Approaches for Observational Exposure Studies (133 pp, 1.21 MB)) and grant approval only to studies that adhere to those principles.

All applications submitted under this solicitation must include a HSRS as described below. Please use the definitions below to determine whether the proposed research involves human subjects, and then prepare a HSRS as explained below in the “HSRS Requirements” section.

Definitions (from 40 CFR Part 26 Subparts A, B, and C) to determine the involvement of human subjects in proposed research:

  • "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 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.  Research involving intentional human exposures have additional requirements based upon the 2004 NRC Report “Intentional Human Dosing Studies for EPA Regulatory Purposes” (The National Academies Press Exit EPA Click for Disclaimer) See Sections 9 - 15.
  • "Observational research" means any human research that does not meet the definition of research involving intentional exposure of a human subject.

Human Subjects Research Statement (HSRS) Requirements

If the proposed research does not involve human subjects as defined above, provide the following statement in your application package as your HSRS:  “The proposed research does not involve human subjects.”  Applicants should provide a clear justification about how the proposed research does not meet the definition (for example, all samples come from deceased individuals OR samples are purchased from a commercial source and provided without identifiers, etc.). 

If the proposed research does involve human subjects, then include in your application package a HSRS that addresses each applicable section listed below, referencing the specific location of the information in the Research Plan, providing the information in the HSRS, or explaining why the section does not apply to the proposed research.  (Not all will apply.)  Please use the definitions provided above to ensure consistency in the interpretation of terminology.  Do not exceed six consecutively numbered, 8.5x11-inch pages of single-spaced, standard 12-point type with 1-inch margins.

NOTE:  Before EPA approves any research involving human subjects, the requirements of the regulations at 40 CFR Part 26 must be met.  For further information, see below.  Also, before EPA approves human observational exposure research, EPA will examine it to ensure consistency with the SEAOES Principles. The federal Office for Human Research Protections requires that federally funded human subjects research only be conducted at facilities covered by a Federalwide Assurance (FWA). An FWA is a document that designates the Institutional Review Board that will review and oversee the research, specifies the ethical principles under which the research will be conducted, and names the individuals who will be responsible for the proper conduct of the research. The factors below are not intended to be exhaustive of all those needed for the HSRRO to provide the final approval necessary for research to be conducted, but provide a basis upon which the HSRRO may grant the conditional approval necessary for the funding process to begin.

Items 1 – 8 must be completed for all studies involving human subjects.  (For studies involving intentional exposures, also complete Items 9 -15.)

  1. Human subjects involvement, characteristics, and design.
    1. Describe and justify the proposed involvement of human subjects in the work being proposed.
    2. Describe the characteristics of the subject population, including their anticipated number, age range, and health status if relevant.
    3. Describe and justify the sampling plan, as well as the recruitment and retention strategies and the criteria for inclusion or exclusion of any subpopulations.
    4. Describe the research material that will be obtained from or about living individuals in  the form of data, specimens, or records.
    5. List any collaborating sites where human subjects research will be performed, and describe the role of those sites and collaborating investigators in the research.
    6. Describe and justify any compensation being provided to subjects for their participation in the research.
    7. Describe the plan for communicating individual and/or aggregate research results to participants, if relevant.
  2. Potential risks to subjects.
    1. Describe the potential risks to human subjects (physical, psychological, financial, legal, or other) and assess their likelihood and seriousness to the human subjects.
  3. Adequacy of protection against risks.
    1. Describe planned procedures for protecting against or minimizing potential risks and assess their likely effectiveness.
    2. Describe planned procedures for the process of obtaining and maintaining informed consent.  Include a description of the circumstances under which consent will be sought and obtained, who will seek it, the nature of the information to be provided to prospective subjects, and the method of documenting consent.
    3. If waiver of some or all of the elements of informed consent or of documentation of consent will be sought, provide justification for the waiver.
    4. Where appropriate, discuss the plans for ensuring necessary medical or professional intervention in the event of adverse effects to subjects.
  4. Protection of vulnerable groups.
    1. Explain the rationale for the involvement of any vulnerable populations, including pregnant women, fetuses, and children if relevant.
    2. Describe the additional protections in place, if any, for protecting vulnerable populations included in the research.
    3. If children are included in the research, describe the process for obtaining parental permission and child assent if relevant.
  5. Protection of privacy and confidentiality.
    1. Describe how data, specimens, and/or records will be collected, managed, and protected, including at collaborating sites, if any, as well as at the primary site.
    2. Indicate who will have access to individually identifiable private information about human subjects.
    3. Describe any additional procedures for the protection of privacy and confidentiality of the human research subjects.
    4. Discuss any mandatory reporting requirements with the potential to come into play during the conduct of the research and describe how these will be communicated to participants if relevant.
    5. Discuss the potential of the research to obtain information about third parties and describe how this will be handled if it occurs.
  6. Relationship between researcher and community.
    1. If the research will take place in a community setting, describe the procedures in place for defining the community, obtaining its involvement in the research, and establishing and maintaining trust.
  7. Potential benefits of the research to the participants and others.
    1. Discuss the potential benefits of the research to the research participants and others.
    2. Discuss why the risks to subjects are reasonable in relation to the anticipated benefits.
  8. Importance of the knowledge to be gained.
    1. Discuss the importance of the knowledge to be gained as a result of the proposed research.
    2. Discuss why the risks to subjects are reasonable in relation to the importance of the knowledge that reasonably may be expected to result.

    The following sections are to be completed for projects involving the intentional exposure of a human subject.  If your proposal does not involve intentional exposures of humans, you may enter “non-applicable” for Sections 9 – 15.

  9. Projects involving intentional exposure of human subjects should only be considered if they have the potential of providing a clear health or environmental benefit or if acquisition of such information is not obtainable by any other means. In no case should the exposure cause lasting harm to study participants.
    1. Provide justification, in advance of being conducted, that the study could contribute to addressing an important scientific question that cannot be resolved on the basis of animal data or other study;
    2. Discuss how the study is designed in accordance with current scientific standards and practices to  i)  address the research question,  ii) include representative study populations for the endpoint in question, and iii) meet requirements for adequate statistical power;
    3. Discuss how the study will be conducted in accordance with recognized good clinical practices, including appropriate monitoring for safety; and
    4. Confirm that the grantee will report comprehensively to their EPA Project Officer, providing the full study protocol, detailed analyses of the data and report any adverse events promptly.
  10. Value of Studies that Seek to Provide a Potential Public Health or Environmental Benefit
    1. Discuss the constitution of the IRB and their ability to consider whether a study has the potential of providing a clear health or environmental benefit to the community.
  11. Criteria for Scientific and Ethical Acceptability
    1. Confirm that the following necessary conditions for scientifically and ethically acceptable intentional human dosing studies have been satisfied: 
      1. prior animal studies and, if available, human observational studies;
      2. a demonstrated need for the knowledge to be obtained from intentional human dosing studies;
      3. justification and documentation of a research design and statistical analysis that are adequate to address an important scientific question, including adequate power to detect appropriate effects;
      4. an acceptable balance of risks and benefits, and minimization of risks to participants;
      5. equitable selection of participants;
      6. free and informed consent of participants; and
      7. review by an appropriately constituted IRB.
  12. Participant Selection Criteria
    1. Discuss how the project design ensures that the following conditions are met in selecting research participants: (i) Selection should be equitable; (ii) Selection of persons from vulnerable populations must be convincingly justified in the protocol, which also must justify the measures to be taken to protect those participants; (iii) Selection of individuals with conditions that put them at increased risk for adverse effects in such studies must be convincingly justified in the protocol, which also must justify the measures that investigators will use to decrease the risks to those participants to an acceptable level.
  13. Payment for Participation
    1. Discuss how IRBs, all relevant review boards, investigators, and research sponsors should ensure that payments to participants in intentional human dosing studies are neither so high as to constitute undue inducement nor so low as to be attractive only to individuals who are socio-economically disadvantaged. Proposed levels of and purposes for remuneration (e.g., time, inconvenience, and risk) should be scrutinized in light of the principles of justice and respect for persons.
  14. Best Practices in Informed Consent
    1. Discuss the proposed process regarding informed consent in intentional human dosing studies and how it compares to best practices.
  15. Compensation for Research-Related Injuries
    1. Discuss how you ensure that participants receive needed medical care for injuries incurred in the study, without cost to the participants.

Management Fees

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 applicants 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.

Competition Policy

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. In addition, if necessary, EPA may clarify threshold eligibility issues with applicants prior to making an eligibility determination.

Agency policy and ethical considerations prevent EPA staff and program 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 this NSF Funding Opportunity Announcement (FOA).  EPA employees cannot endorse any particular application.

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.

By submitting an application in response to this announcement, the applicant grants the EPA permission to make limited disclosures of the application to technical reviewers within 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.

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.

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.

EPA 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. Please note that 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.  

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.

SECTION VI. NSF PROPOSAL PROCESSING AND REVIEW PROCEDURES  

Programmatic Review

The EPA internal programmatic review will be conducted by technical experts from the EPA, including individuals from the Office of Research and Development (ORD), program, and regional offices involved with the science or engineering proposed. 

Those applicants who are to be further considered for EPA funding 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 to EPA within one week 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 EPA 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 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 (outputs/outcomes) 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.

Human Subjects Research Statement (HSRS) Review

Applications being considered for funding after the Programmatic Review that involve human subjects research studies will have their HSRS reviewed by EPA’s HSRRO prior to award.  The HSRRO will review the information provided in the HSRS and the Research Plan to determine if the ethical treatment of human subjects is described in a manner appropriate for conditional approval to be granted.

SECTION VII. AWARD ADMINISTRATION INFORMATION

Non-Profit Administrative Capability Review

Non-profit applicants that are recommended for EPA 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.

Disputes

Disputes related to EPA funding decisions made following EPA’s programmatic review 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 EPA Contact identified in the announcement.

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:  A grant applicant must agree to meet all EPA requirements for studies using human subjects prior to implementing any work with these subjects. These requirements are given in 40 CFR Part 26.  Studies involving intentional exposure of human subjects who are children or pregnant or nursing women are prohibited by Subpart B of 40 CFR Part 26.  For observational studies involving children or pregnant women and fetuses please refer to Subparts C & D of 40 CFR Part 26. U.S. Department of Health and Human Services regulations at 45 CFR Part 46.101(e) have long required "... compliance with pertinent Federal laws or regulations which provide additional protection for human subjects." EPA’s regulation 40 CFR Part 26 is such a pertinent Federal regulation. Therefore, the applicant's Institutional Review Board (IRB) approval must state that the applicant's study meets the EPA's regulations at 40 CFR Part 26.  No work involving human subjects, including recruiting, may be initiated before the EPA has received a copy of the applicant’s IRB approval of the project and the EPA has also provided approval.  Where human subjects are involved in the research, the recipient must provide evidence of subsequent IRB reviews, including amendments or minor changes of protocol, as part of annual reports.

    Guidance and training for investigators conducting EPA-funded research involving human subjects may be obtained here:
    Ethics, Regulations, and Policies
    Human Subjects Research at the Environmental Protection Agency: Ethical Standards and Regulatory Requirements

  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. 2131-2159.  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: Post 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 EPA Information Quality Guidelines (EPA IQG).  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 EPA Project Officer of any papers published after completion of the grant that were based on research supported by the grant.  NCER posts references to all publications resulting from a grant on the NCER web site.

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

    EPA also anticipates that awards made under this announcement to be funded with FY13 appropriations will be 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. Subject to the language in the FY 13 Appropriation Act (or Continuing Resolution), EPA anticipates that non-profit or for-profit organizations that are covered by these prohibitions will be ineligible to receive an award under this announcement.

  10. 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 Exit EPA Click for Disclaimer.

    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.

  11. EPA 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 the Exchange Network website. Exit EPA Click for Disclaimer

  12. 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.

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